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# Regulate Silver Fluoride as Drug: Petition
- URL: https://www.fdaweb.com/regulate-silver-fluoride-as-drug-petition/
- Published: 2025-03-25T12:00:00.000Z
- Updated: 2026-09-14T14:56:07.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5158887

Advantage Silver Dental Arrest, Seattle, WA, is petitioning FDA to regulate silver diamine fluoride and silver fluoride agents for dentin hypersensitivity as drugs rather than medical devices and thus rescind premarket clearance of such products. The 3/17 [petition](https://downloads.regulations.gov/FDA-2025-P-0832-0001/attachment%5F1.pdf?ref=fdaweb.com) says silver diamine fluoride is a liquid drug that is topically applied in minute amounts to dental cavities to arrest tooth decay by killing the tooth decay bacteria (silver) and rehardening the tooth mineral (fluoride).

The petition says that public health researchers have demonstrated enormous savings when silver diamine fluoride is used instead of traditional dental treatment, which, it says, is important in the U.S. because severe childhood tooth decay occurs mainly among the poor and underserved populations whose care is paid for by Medicaid.

It says 38% silver diamine fluoride has completed all of the preNDA steps for approval as a properly labeled drug to treat severe early childhood caries.

The petition asks that FDA rescind Class 2 510(k) clearances of all silver diamine fluoride and silver fluoride agents for tooth hypersensitivity and require they be removed from the market unless and until they are the subject of an approved NDA. It also asks that the Office of Combination Products be instructed to classify new silver diamine fluoride and silver fluoride agents as drugs.