510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PHRClass II

Diammine Silver Fluoride Dental Hypersensitivity Varnish

21 CFR 872.3260 / Dental
FDA source (opens on fda.gov)

PHR is the FDA product code for Diammine Silver Fluoride Dental Hypersensitivity Varnish, a class II device type, regulated under 21 CFR 872.3260. FDA's definition for this code reads: "Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PHR
Device name
Diammine Silver Fluoride Dental Hypersensitivity Varnish
FDA definition
Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity.
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
8
Ingested recalls
0

Clearances, product code PHR

By decision year
8 clearances under product code PHR with a decision year between 2014 and 2025, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PHR by decision year
YearClearances
20141
20181
20232
20242
20252

Applicants with the most clearances

Product code PHR
Applicants holding the most 510(k) clearances under product code PHR
ApplicantClearances
Belport Company, Inc., Gingi-Pak1
Centrix, Inc.1
Cooley Consulting, Inc.1
Elevate Oral Care, LLC1
Kids-e-Dental LLP1
Sdi Ltd.1
Tedequim SRL1
Young Dental Manufacturing Co 1, LLC.1

Companies listing this code with FDA

Companies whose registered establishments list this code