DeviceClearance

Product code PHR— Dental

Black Diamond

Classification name
Diammine Silver Fluoride Dental Hypersensitivity Varnish
Device class
Class 2
Regulation
21 CFR 872.3260
Advisory panel
Dental
Total cleared
8
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PHR under 21 CFR 872.3260, via openFDA

Market context for product code PHR

FDA has cleared 8 devices under product code PHR between 2014 and 2025, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PHR

Recent clearances under product code PHR

Data sourced from openFDA. This site is unofficial and independent of the FDA.