510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160377Substantially Equivalent

V-varnish Premium

Vericom Co., Ltd., Chuncheon-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160377 is the FDA 510(k) clearance record for V-varnish Premium, a class II device, cleared for Vericom Co., Ltd. on under FDA product code LBH (Varnish, Cavity). FDA records list 20 510(k) clearances for Vericom Co., Ltd., from to . As of , FDA records show no recalls naming K160377.

Clearance record

Decision date
Received
(296 days to decision)
Product code
LBH Varnish, Cavity
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Vericom Co., Ltd. 48, Toegyegongdan 1-Gil,, Chuncheon-Si, KR
510(k) summary
Summary PDF
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