510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222323Substantially Equivalent

Black Diamond

Elevate Oral Care, LLC, West Palm Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222323 is the FDA 510(k) clearance record for Black Diamond, a class II device, cleared for Elevate Oral Care, LLC on under FDA product code PHR (Diammine Silver Fluoride Dental Hypersensitivity Varnish). FDA's definition for product code PHR reads: "Applied to tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity". FDA records list 5 510(k) clearances for Elevate Oral Care, LLC, from to . As of , FDA records show no recalls naming K222323.

Clearance record

Decision date
Received
(325 days to decision)
Product code
PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Elevate Oral Care, LLC 346 Pike Rd., West Palm Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHR

Trailing 12 months

FDA records hold no clearances under product code PHR in the trailing twelve months.

FDA records show no clearances under product code PHR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PHR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260