A common question I receive is whether hydroxyapatite is FDA approved. The short answer is: not specifically for dental caries prevention. Below I explain what that means and why it matters for patients and practitioners.
Fluoride varnishes used in dental offices have obtained FDA clearance as Class II medical devices for indications such as cavity liners and tooth desensitizers.
That clearance applies to those specific uses, not to claims of caries prevention. Nonetheless, fluoride varnishes are commonly used “off-label” for caries prevention, a practice permitted under FDA rules when clinicians rely on scientific rationale and clinical judgment.
Why isn’t hydroxyapatite FDA approved for dental use yet?
Hydroxyapatite is approved for certain medical applications, but it does not currently carry FDA approval for caries-preventive claims in oral care. In the U.S., the FDA historically requires specific evidence and regulatory pathways for products that claim to prevent cavities, and non-fluoride toothpastes have not been granted those claims.
This situation does not imply that hydroxyapatite—or fluoride—are ineffective. Rather, it reflects the regulatory framework and the evolving body of research around oral care ingredients. Many clinicians prescribe and use treatments off-label when evidence and clinical judgment support those uses.
The FDA’s guidance on off-label use emphasizes that health professionals should be well informed about the product, base its use on sound scientific evidence, and document outcomes. FDA approval is not a prerequisite for clinicians to use fluoride varnish off-label, and the same principle applies to hydroxyapatite when clinicians judge it appropriate.
In short, absence of an FDA indication for hydroxyapatite as a caries preventive agent does not automatically negate its safety or clinical utility. It does mean clinicians and consumers should understand the regulatory distinctions and consider the available evidence.
So, in the absence of FDA approval, what should you look for in a hydroxyapatite toothpaste?
Currently the FDA regulates toothpaste primarily as an OTC product, and in many views that classification is inadequate given toothpaste’s direct effects on the oral microbiome and potential systemic exposure over a lifetime. Until clearer regulation or labeling is established, I recommend evaluating hydroxyapatite products by a few practical quality standards to help ensure efficacy and safety.
Below are criteria I consider important and encourage clinicians and consumers to share.
1. Does it work on teeth?
Peer-reviewed clinical studies are the gold standard. Multiple peer-reviewed trials and systematic reviews have reported benefits of hydroxyapatite for reducing caries progression, decreasing sensitivity, and contributing to enamel remineralization and whitening effects.
Independent assessments, such as those by environmental and safety organizations, also support a favorable safety profile for hydroxyapatite. For example, hydroxyapatite has been given low concern ratings by some organizations for environmental toxicity and bioaccumulation.
2. Is it safe for the rest of the body?
It’s important to consider whole-body safety, not just effects on teeth. The Scientific Committee on Consumer Safety (SCCS) in the EU has evaluated nano-hydroxyapatite and issued a final opinion addressing concentrations and particle characteristics appropriate for oral cosmetic products.
According to the SCCS opinion (March 2023), hydroxyapatite (nano) is considered safe when used in toothpaste at concentrations up to 10% and in mouthwash up to 0.465%, provided the particles meet specific shape and size characteristics and are not surface modified. When selecting products, look for manufacturers that can document compliance with those specifications and provide safety data.
Manufacturers that transparently share the origin of their hydroxyapatite and safety assessments allow clinicians and consumers to make better-informed choices.
Will the FDA approve hydroxyapatite one day?
Regulatory change takes time, but there are encouraging signs of adoption in professional circles. In 2024, new procedure codes were adopted for the use of hydroxyapatite varnishes, reflecting growing recognition among dental payers and professional organizations.
For example, a code has been established specifically for application of hydroxyapatite regeneration medicament per tooth (D2991), with coverage rules that may be adopted by certain payers. Wider acceptance typically follows accumulation of clinical evidence, payer recognition, and professional advocacy.
We have seen similar trajectories with other dental materials and treatments: initial clinical adoption, followed by coding and payer recognition, and later broader acceptance. It’s reasonable to expect continued progress for hydroxyapatite as the evidence base grows.
In the meantime, what can you do?
If you are a patient or a practitioner interested in broader access and recognition of hydroxyapatite products, you can take practical steps to support change. Writing to insurance companies, professional organizations, and regulators to share clinical observations and request coverage or clearer guidance helps accelerate recognition.
Below is an example letter that clinicians can adapt when advocating for insurance coverage or regulatory consideration of hydroxyapatite varnish. It is offered as a template to communicate clinical experience, patient benefits, and the potential cost savings of minimally invasive approaches.
Example letter urging insurance companies and/or FDA approval of hydroxyapatite
Staci Whitman:
Subject: Request for Coverage of Hydroxyapatite Varnish
Dear {{NAME}},
I am writing to advocate for inclusion of hydroxyapatite varnish as a covered benefit in your dental plans. As a pediatric dentist with nearly twenty years of clinical experience, I have seen the positive effects of this material on children’s oral health.
Hydroxyapatite varnish offers a safe, minimally invasive method to arrest and remineralize early lesions. Unlike restorative procedures that require local anesthesia, drilling, and sometimes sedation, varnish can be applied topically at routine visits to manage disease progression. This reduces the need for more invasive care, lowers anxiety for young patients, and can decrease overall costs for families and insurers.
In my practice, use of hydroxyapatite varnish has been associated with fewer fillings and fewer anesthesia-related visits. Early intervention with varnish helps prevent the progression of cavities that would otherwise require restorative treatment. Additionally, hydroxyapatite may positively influence the oral microbiome in ways that differ from fluoride.
Observed benefits include:
- Reduced number of restorative procedures in pediatric patients.
- Fewer anesthesia or sedation visits due to noninvasive treatment options.
- Improved early intervention outcomes through topical applications during recall visits.
Recognizing hydroxyapatite varnish—such as by covering code D2991—would demonstrate a commitment to preventive, patient-centered pediatric dental care and could yield long-term cost savings by avoiding more extensive treatments.
Thank you for considering this request. I am available to provide further information, clinical data, or to answer questions.
Sincerely,
Anastacia M Whitman, DMD, IFMCP
Board-Certified Pediatric Dentist