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FDA PRODUCT CODE · CLASS II

PHR — Diammine Silver Fluoride Dental Hypersensitivity Varnish

Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.

DEVICE CLASS
Class II
REGULATION
21 CFR 872.3260
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K250222Belport Company, Inc., Gingi-Pak · 510k2025-05-07
K241041Young Dental Manufacturing Co. 1, LLC · 510k2025-02-28

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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