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Off-Label and Totally Legal: What the FDA Won’t Say About Fluoride Varnish & SDF

May 29, 2025 By Trish Walraven Leave a Comment

Fluoride Varnish and Silver Diamine Fluoride (SDF)

Let’s play a little game. Imagine your fluoride varnish brush could talk. You pick it up, ready to slather it across the facial and lingual surfaces of your patient’s teeth, and it whispers:

Psst… I’m only here for sensitivity.”

Excuse me? We both know that’s not the real reason you’re using it. You’re using it to prevent cavities. So why the double life?

Not-So-Secret Agents: Fluoride Varnish & SDF

If you work in dentistry, you know there are two magical fluids we love using to fight decay without breaking out the drill: fluoride varnish and silver diamine fluoride (SDF).

But here’s the kicker: neither is FDA-approved for the thing we all use them for – you know, the actual preventing or arresting of cavities. They’ve got their little badges that say, “I’m here to reduce sensitivity,” and that’s it. It’s like hiring a security guard to scare off pigeons and they stop a bank robbery instead. Not exactly their “official” job, but they’re killing it nonetheless.

So… Are We Doing Dentistry Wrong?

Not at all. This is what the grown-up version of medicine looks like: off-label use. That means we, as clinicians, are allowed to use products in ways that aren’t specifically written on the packaging, as long as there’s good science behind it and we’re not just winging it with snake oil and hope.

Fluoride varnish has been used off-label for decades to prevent caries. Every major dental organization (ADA, AAPD, CDC) backs it. It’s reimbursed by Medicaid for that purpose in many states. Even pediatricians – outside of a dental setting – are authorized to apply fluoride to children’s teeth under certain medical guidelines. But the label? Still just for hypersensitivity.

Silver diamine fluoride (SDF) – same deal. It got FDA clearance in 2014 for sensitivity. But its real superpower is stopping decay in its tracks. You paint it on a mushy lesion and – bam! – it freezes like Elsa just sang at it. Black, hard, ugly-but-healthy decay. Not glamorous, but incredibly effective, especially for kiddos, elders, and patients who can’t tolerate traditional treatment.

Why Not Just Change the Label?

Here’s the not-so-fun part: getting a new FDA indication is expensive. Like, “we could build a small dental school for this money” expensive. Most of the companies that make fluoride varnish and SDF are not Big Pharma. They’re more like Little-To-Medium-Sized Dental Supply. If their product is already being widely used and endorsed for the off-label thing? Why spend millions for a gold sticker that says “Approved”?

Also, if it ain’t broke (and no one’s getting sued), they’re not fixing it.

The Ethics and the Eyebrow Raises

Now, I’m not saying you shouldn’t know what’s on-label and what’s not. It matters. Patients deserve transparency, and we owe it to them to explain why their kid’s teeth are turning black (SDF, looking at you) or why we’re applying fluoride varnish after a cleaning even though they don’t have “sensitive teeth.”

The next time you brush on that fluoride varnish or dab a bit of SDF, give a little nod to its secret identity. Off-label? Definitely. Totally legal? You bet. Cavity-fighting? That’s the plot twist they didn’t print on the package.

TL;DR for Your Patients (and Curious Colleagues)

Fluoride varnish: FDA says it’s for sensitivity. We use it for cavities.
SDF: FDA says it’s for sensitivity. We use it to stop decay cold.
Both are off-label for caries, but not off-limits.
Science is on our side.
No one’s getting arrested. (Except maybe the cavities.)

What’s your take? Are we stretching the label, or just catching up to the science? Will this be one more talking point for those on the anti-fluoride side? Share your thoughts in the comments.

References

FDA 510(k) Summary for Advantage Arrest (SDF): FDA Clearance Database
ADA Clinical Practice Guidelines for SDF: ADA.org
ADA Topical Fluoride Guidelines: ADA.org
CDC’s Take on Fluoride Varnish: CDC.gov
AAPD Policy on Fluoride Therapy: AAPD.org

Dentists Rejoice over the Leica Camera Tariffs

May 5, 2025 By DentalBuzz Staff 1 Comment

*^{Distracted Dentist using patient’s nose as a fulcrum to capture foot shot}*

There’s a strange, bougie scent in the air. It smells like high-end modular furniture, fine leather, and the vague aroma of eugenol. That’s right – it’s the company’s 100th anniversary, here in Leica Land, where a digital rangefinder costs more than an operatory chair, and yet somehow, can’t even help identify dental decay.

Strap on the laughing gas, because we’re about to dig into an elite camera company’s favorite stereotype:

“Only rich dentists shoot with Leicas.”

But here’s the paradox no one talks about: the Leica M11 is completely useless inside an actual mouth. Let that sink in. A $9,000+ camera that can capture the soul of a Parisian alley at dusk… but couldn’t diagnose a fractured molar if its red dot depended on it.

The Red Dot of Irony 🔴
Ah, Leica. The brand that makes grown humans weep with joy over manual focus rings and brass top plates. The M11 is their crown jewel:

60MP BSI CMOS Sensor
ISO range wide enough to photograph your regrets
And a shutter sound that’s smoother than a freshly polished zirconia crown

But let’s get one thing straight: the Leica M11 is not an intraoral camera. It’s a pricey piece of dental cosplay gear – perfect for the dentist who wants to look like they know photography while they’re in between hygiene checks, but who’s still using a cheapie USB scope to document someone’s smile transformation.

Let’s compare:

Feature	Leica M11	Actual Intraoral Camera
Autofocus	Manual only. Good luck.	Yes, like a normal person.
Ergonomics for tight spaces	Brick with a strap	Designed for mouths
Lighting	Bring your own flash, dentist bro	Built-in LED lighting
Usable in dentistry	LOL	Yes

“But It’s for the Experience!” – Every Leica Owner, Defensively
Leica owners swear it’s not about specs – it’s about soulful craftsmanship. Right. And dentists don’t care about teeth and their patients’ health – they just crave the existential thrill of the thought that any moment, those sharp canines and incisors will snap shut on their fingers. But go off, Dr. Moneybags. Slap a Summilux 50mm on that beast and try to explain to your patient why you need 60 megapixels of their uvula.

There’s a strange prestige economy among certain dentists that are part of the “egosystem” – if you can’t flex on your peers at a CE conference, what’s even the point of doing restorative dentistry? And nothing says, “I’ve moved past Nikon peasantry,” like wearing a Leica around your neck that hasn’t taken a single clinical shot.

Memo to Leica: Deny the Dentist – We Dare You
You know what’s worse than being the punchline? Desperately trying to look above it while still cashing in. Leica, we see you. Sitting pretty on your walnut display boxes, polishing brass knobs while pretending you’re too dignified to acknowledge that your M11 is the camera of choice for the Clinically Bored™.

You’ve never corrected the meme. Never addressed the elephant in the operatory. You’ve said nothing – because deep down, you like that people believe your rangefinders are purchased in bulk by dental practitioners who needed a tax write-off after buying a Cybertruck.

Let’s call it what it is: Leica doesn’t mind being the Rolex of cameras, even if it means being synonymous with nitrous oxide and Fridays off. They’ve embraced the aesthetic of minimalist elegance, hand-crafted precision… and thinly veiled financial overcompensation. And the US tariffs this year are not an obstacle – they simply add one more level of exclusivity. Happy 100th to you, too, old sport.

You could have released an affordable, beginner-friendly model for struggling photojournalists. You could have doubled down on legacy users, street photographers, and war correspondents.

But no – you released the Leica M11-P (Practitioner) with a sapphire screen and 256 GB internal memory, like a camera version of a platinum dental grill. And let’s not even talk about the black paint edition. You don’t fight the dentist stereotype, Leica, because you’re secretly flattered by it. And that’s the saddest part of all.

Final Thoughts: Come for the Myth, Stay for the Copium
So here’s to the Leica M11: a camera of unmatched engineering, wielded by a person who just permanently seated your new dental crown and now wants to show you a “soft” (slightly blurry) slideshow from their vacation in Milan – shot wide open at f/1.4, obviously. Let the myth live on, because Leica certainly isn’t killing it. In fact, they’re minting it. Every time a new model drops, another dentist gets their wings (and a new leather strap).

No shame in owning an M11 – unless you’re actively trying not to look like a dentist with a midlife crisis in JPEG format, because apparently RAW only exists when necrotizing gingivitis is present. Either way, congrats on reaching the final form of dentistcore.

It’s not OK for your dental practice to use free cloud-based communication

June 10, 2021 By DentalBuzz Staff 2 Comments

It was nice – the way that the HIPAA police looked the other way as we all figured out how to take care of each other during the worst of 2020 – but now that we’re over that hump, emergency usage is no longer an acceptable excuse for a security breach or a privacy violation.

Before you begin defending the use of cloud-based messaging in your office by explaining that you never share protected health information (PHI) there, or that you have other security measures in place to protect you from malware, or hope that the regulations only apply to large organizations and not small practices, know that there is one rule that is hard and fast when it comes to using communication tools in healthcare:

Only Paid Versions are HIPAA compliant.

This is because free versions do not include something called a Business Associate Agreement (BAA). A signed BAA is required in order for cloud-based systems to be HIPAA compliant. It’s not as though you’ll ever need to exercise an audit, but if one becomes necessary, this is the safeguard in place to allow you to have the ability to prove that a program such as Slack or Microsoft Teams was not the source of the privacy breach. Here’s the thing: even if you’ve never shared sensitive patient information on any platform, it doesn’t matter if you can’t prove it!

And that right there is the crux of the matter. While you may think this threat is a flaming fear spear, remember, data has value, and there are those out there who seek it out in order to further enrich themselves. We all have an obligation to follow the recommendations set for us professionally. After all, you’re a patient, too. Maybe not always where you work, but if you have a body, somewhere you’re a patient in an office’s system, and as such, you’d like to know that the practices you visit are managing all of their privacy matters correctly. If they’re no being careful with something simple like communications, it makes you wonder where else they’re making mistakes.

While this is not a comprehensive list, these are the most common communication platforms that dental practices (and healthcare practices in general!) may encounter when they’re looking for a way to collaborate with their team members, along with the current pricing that users should expect to pay in order to safely utilize the software anywhere in their business.

As you can see, it starts to get expensive, very quickly, if you’re dead set on using one of these platforms. They don’t even do a good job of getting the right person’s attention at the right time, especially if people in the office don’t just sit at one computer all day. You can get so much more for your money once you accept that healthcare businesses must have a paid subscription to use cloud-based communication. It’s just a matter of doing a simple Google search to find many other solutions more tailored to dentistry, at a lower cost per year, per user, per month, whatever. Making do with the programs above means that you end up paying for things that most team members aren’t even using, like Microsoft Word, or screen sharing, or video conferencing.

In case you’re still confused, here’s the concise answer for each of the free versions of these platforms.

Is Slack HIPAA compliant? No.
Is Microsoft Teams HIPAA compliant? No.
Is WhatsApp HIPAA compliant? Never.
Is Skype HIPAA compliant? No.
Is Google Chat HIPAA compliant? No.
Is Zoom HIPAA compliant? No.

And for final clarification, you can become HIPAA compliant in the use of five out of six of these applications, but only once you’ve paid a subscription fee per user, disengaged any non-compliant third party integrations (so many rules!) and received a signed business associate agreement.

Otherwise, it’s time to look elsewhere.

Resources:

HHS.gov Business Associate Agreements: https://www.hhs.gov/hipaa/for-professionals/covered-entities/sample-business-associate-agreement-provisions/index.html

Slack Enterprise Grid for Healthcare (otherwise NOT HIPAA compliant): https://slack.com/resources/why-use-slack/hipaa-compliant-collaboration-with-slack and https://slack.com/help/articles/360020685594-Slack-and-HIPAA

Microsoft Teams for Healthcare: https://www.microsoft.com/en-us/microsoft-365/compare-microsoft-365-enterprise-plans

Zoom for Healthcare: https://zoom.us/healthcare

Lead Aprons feel so good! Here’s why.

October 30, 2019 By DentalBuzz Staff 6 Comments

Ever since you were a kid, you’ve known this: there’s a comfort that settles through you right before getting dental x-rays. You notice when the heavy shield gets draped over your shoulders and tummy that it’s a bit easier to relax, to open your mouth and let the dental professional twist things in your mouth at weird angles.

That comfort is called Deep Touch Pressure. It’s what swaddled babies feel with a tightly-wrapped blanket, what dogs experience when they wear a Thundershirt, and what up until recently has been known as a soothing technique primarily for kids and adults who are on the autism spectrum.

When Deep Touch Pressure is applied over a wide area, it switches the body from running its sympathetic nervous system to its parasympathetic nervous system. Deep touch pressure gives a sense that it’s okay to leave the “flight or fight” mode and settle into a “rest and digest” mode instead.

The sympathetic nervous system engages when you anticipate anything that is challenging, scary, or painful, while the parasympathetic nervous system is responsible for releasing feel-good endorphins, relaxing muscles, and creating a sense of peace and calm.

To review, then, this person has their Sympathetic Nervous System fully engaged:

Person holding mouth as dentist and assistant sneak up behind.

Next, look at this little puppy enjoying its Parasympathetic Nervous System response:

No rhetorical questions here. You know you could just be the puppy forever.

There are stories like this one from Dr. Spindel’s blog that tell of patients wanting to keep the lead vest on for their entire appointment as a sort of security blanket. Only unlike her, once the x-rays are taken, most of us are nakedly shocked back into anxious uncertainty with the removal of the deep touch pressure feeling.

Um, hello?

You know exactly where this is going, right?

More than just a heavy Snuggie.

Pretty much every retail and online shop sells Deep Touch Pressure products now. This therapy is found in the form of weighted blankets which are much more comfortable and heavier than lead shields so yay!

If you’re a patient who gets a little anxious going to the dentist and you already have a weighted blanket that you shelled out $200 for when they first became available, try bringing the blanket to your next appointment to see if it helps.

And for those dental professionals reading this, you might consider getting a few weighted blankets for your office. You can find them as low as $50 each but current pricing hovers around $75 these days. Here’s an inexpensive fifteen-pounder seen in the local warehouse store this weekend:

Need something a little more rugged? These weighted blankets from DentaCalm are available in different sizes, can be wiped clean, and come in two colors:

Dental fear is real.

Even people who have been going to the dentist forever get nervous sometimes, like it wells up from some organic “gonna get you” place in our primitive perimeter warning system. Deep touch pressure helps to inhibit dental anxiety. Except for the anxiety within the dentists when slinking into a dental chair to get their teeth cleaned when there’s an opening in the schedule. Their stress comes from the fear that they’re about to be exposed as a fraud by their hygienist if the dentist’s gums bleed even one little speck during their preventive care. Sorry, the weighted blanket is simply not going to make up for not flossing.

Feeling calm is better.

Instead of shaming dentists for their questionable home care, then, let’s all get the word out that weighted blankets are more than a fad, or that they’re used as merely an excuse to stay in bed longer in the morning.

Worried about the stigma or mood-altering effects of using laughing gas (nitrous oxide)? Weighted blankets create a similar sense of well-being without masks, drugs, or that loopy feeling. Many practices have already discovered the benefits of weighted blankets, and feature this amenity on their websites as one of the ways they make dental visits easier.

Please share this link with your dental professionals, your patients, and your friends. And as always, DentalBuzz does not use affiliate links or accept ad payments, so feel free to browse the resources list and share your experiences with weighted blankets (or any good deals you discover!) in the comments below.

Resources and further reading:

Can I please wear the heavy vest: https://lspindelnycdds.blogspot.com/2019/05/can-i-please-wear-heavy-vest.html

The Allure of the Weighted Blanket: https://www.brainfacts.org/Thinking-Sensing-and-Behaving/Sleep/2018/The-Allure-of-the-Weighted-Blanket-112918

Penn Medicine: More than just a fad: https://www.pennmedicine.org/updates/blogs/health-and-wellness/2019/february/weighted-blankets

HippoHug: https://hippohug.ca/2018/12/12/anxious-at-the-dentists-office-try-a-weighted-blanket/

TruHugs Research Blog: https://blog.truhugs.com/deep-pressure-stimulation-used-during-various-dental-procedures-to-curb-anxiety-symptoms/

DentaCalm: https:/dentacalm.com

Sommerfly Wipe-Clean Relaxer: https://www.sommerfly.com/collections/wipe-clean-collection/

What is this $&!% on my toothbrush?

September 4, 2019 By Trish Walraven 2 Comments

This morning I threw my toothbrush into the toilet. That’s where it belongs, apparently, since I can’t seem to do the right thing to keep germs off of it.

See, a few years ago there was a big news story about the aerosols that are created with every toilet flush. I call this phenomenon “Fecal Fallout.” Let me explain: if a toothbrush is stored in the open air near a toilet, the debris from the bowl can be carried into the air and then sprinkled down onto anything within a six foot radius in a plume of doom. As a result, we may find ourselves brushing with the e.coli germs from feces if we’re not keeping our toothbrushes covered.

So if we’ve been keeping them covered, that’s not good either? Covering causes yet ANOTHER PROBLEM:

The growth that you see in this and the following image was accelerated by a few days, but this is really what happens! If we close in the moisture on our toothbrushes, we might as well invite a whole slimy rainforest to grow in there. It’s not just our toothbrushes that are being over-helicoptered. Mouthguards also tend to grow things on them if left unattended:

Nope. No way. I welcome the Demons Of TMJ Disturbance to visit me and make me dream about my teeth falling out all night. Sad that I’d rather grind myself down to gummy nubs than to have to clean that nightguard off and sleep in it again.

When someone tries to gross us out with a problem, there’s a reason behind it, because there must be an answer, a solution to the horrible thing that we want to prevent. What I like is that this solution happens to be quite economical and user-friendly.

No. Not that economical. You’re going back to the whole idea of “things that should be in the toilet.” But at least you’re thinking dry.

The Toothbrush Shield

As a dental hygienist, at times I’ve been merely satisfied with knowing my patients are using a toothbrush, but lately I’ve decided to acknowledge that they can be vectors for pathogens to invade our bodies if not managed properly. What’s excessive though, is how there are all these UV blue-light sanitizers on the market and other expensive gadgets you really don’t need to keep your toothbrush healthy. Along that path, I discovered the one thing that actually makes a lot of sense:

These covers both wick away moisture from your toothbrush and provide a physical barrier between your bristles and anything you don’t want them to touch, like your family’s other toothbrushes, bathroom cleaning chemicals, or stray hairs. I will never put my toothbrush in another plastic case now that I know about Toothbrush Shields.

This product is so obvious that I’m surprised I’m just now finding out about it. I want to get the word out why wicking sleeves should be as universal to our lives as something like plastic baggies. This particular wicking sleeve is designed for your toothbrush, and here are the reasons why I am endorsing the Toothbrush Shield:

Affordable. A pack of 10 Toothbrush Shields retails around $4.00 at the time of this writing, and each one is effective for up to 7 days.
Simple to use. Slip the cover on right after brushing, then your toothbrush can go anywhere! Your bathroom counter, luggage, purse, kids’ backpacks for quick sleepovers. No fumbling for a way to protect toothbrushes from questionable environments.
Hospital-grade. The lightweight but quality material feels almost identical to the larger sleeves I’ve used to keep saliva and blood off of patient headrests in the dental practice.
Made in the USA. Not only that, the company is woman-owned.

Part of that last bullet point is how I found out about this product. In the United States, 97% of dental hygienists are women. Other than kindergarten teachers (see the 2018 Labor Statistics here), the rest of the professions aren’t even close to having this extreme gender skew. So a short time ago I was at a conference exclusively for the dental hygiene profession – for all these women, essentially – where I was given a few samples of the Toothbrush Shield. Mind you, I was carrying a trade show bag heavy with familiar toothpastes, flossers, mouthwashes, and brushes from all the dental hygiene exhibitors. But this one product stood out, especially since I’d never seen anything like it before.

That’s where the “woman-owned” part comes in. While the person who invented the Toothbrush Shield is not a dental hygienist by profession, she has the insight to realize where her biggest advocates are poised, and most importantly, who they are, and what drives them.

I’d like to introduce her to you. She is Susan Klinsport, an entrepreneur with a background ripe for solving the problem of germs and wet toothbrushes that she encountered in her personal life. Her experience working with engineering companies gained her the access to materials testing, scientific consultations, and manufacturing, and has resulted not only in the Toothbrush Shield, but she has also designed the larger version as a Mouthguard Shield.

I didn’t snag any of these Mouthguard Shields at the conference, so I asked for some images from Susan herself. I know, right? She’s like totally my best friend now. That’s because after the show was over, I was like “Hey,” and she was like “What” and I emailed her to ask about her story and everything. And she was really cool about it so here we are, on DentalBuzz, getting the word out about a simple, effective product that will protect yours and your patients’ toothbrushes by keeping them covered every day, and that takes the place of plastic cases and rolled up toilet paper when traveling.

So where can you get Toothbrush Shields? Probably just down the street! You’ll find them in stock at CVS, Walmart, and Rite-Aid. Or if they’re not on your local pharmacy shelves, you can purchase online from many retailers, including the IntellidentProducts.com website that will take you to the Walgreens retail page where a box is on sale for $2.28 currently. Good deal! Even if they’re privately labeled, they are still the same product, as you can see below:

Critical Cleanliness

Patients undergoing cancer therapy are especially vulnerable to secondary infections, so oncology clinics and individuals are able to purchase Toothbrush Shields in bulk here on the website at SideEffectsSupport.com, the world’s leading resource for minimizing oral effects of cancer treatment. The shields are also included as part of the Oral Cancer Rescue Kit as pioneered by Jill Meyer-Lippert, RDH of SideEffectsSupport.com and Jennifer Brown, RDH, BS of CARTI Cancer Center in Arkansas.

Aetna has gotten the message as well. The insurance company is currently including the Toothbrush Shields in their oral hygiene care packages as part of their Rush to Brush program, thanks to the efforts of Susan Klinsport and Dian Baker, PhD RN. This program is designed to decrease patients’ risks of acquiring infections during hospital stays.

Final words

There is also a great news story featuring Susan and the Toothbrush Shield that I wanted to share here:

I’m now using the Toothbrush Shields over my manual toothbrush as well as my electric ones. Why so many brushes? It’s because I’m currently going back and forth, comparing my previously shelved Philips Sonicare with the new Braun OralB that I received for free from the same conference, but that’s a story for a future article. All have been easier to remember to re-cover, and I’m looking forward to traveling with them now instead of closed-in plastic caps that I have to keep up with.

As for the toothbrush I threw in the toilet? It’s got a new job: scrubbing the dark grime out of the washing machine.

Trish Walraven RDH, BS has been curating DentalBuzz.com since 2008 as a casual place for dental professionals and their patients to explore dentistry in ways that make their lives better. This does not include firm toothbrushes, which is probably an equal factor for tossing that one that ended up in her laundry room.

Disclosure and copyright: Other than the samples, I did not receive any other form of compensation for this article. Feel free to share this information on your dental blogs, social media pages, or any habitats where patients and colleagues tend to dwell.

Resources and further reading:

https://www.allure.com/story/toothrbush-germs-bacteria

https://www.usatoday.com/story/news/nation-now/2017/04/06/youre-probably-brushing-your-teeth-fecal-matter/99785026/

https://www.onhealth.com/content/1/toothbrush_germs_facts

https://www.guardiandirect.com/resources/articles/shocking-facts-about-your-toothbrush