510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062683Substantially Equivalent

Enamel Pro Varnish

Premier Dental Products Co, Plymouth Meeting PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K062683 is the FDA 510(k) clearance record for ENAMEL PRO VARNISH, a class II device, cleared for Premier Dental Products Co. on under FDA product code LBH (Varnish, Cavity). FDA records list 44 510(k) clearances for Premier Dental Products Co., from to . As of , FDA records show no recalls naming K062683.

Clearance record

Decision date
Received
(74 days to decision)
Product code
LBH Varnish, Cavity
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Premier Dental Products Co. 1710 Romano Dr., Plymouth Meeting PA
510(k) summary
Statement
Third party review
No

Clearances, product code LBH

Trailing 12 months
6 clearances under product code LBH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LBH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260