510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K080814Substantially Equivalent

Voco Profluorid Varnish

Voco GmbH, Cuxhaven, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080814 is the FDA 510(k) clearance record for VOCO PROFLUORID VARNISH, a class II device, cleared for Voco GmbH on under FDA product code LBH (Varnish, Cavity). FDA records list 78 510(k) clearances for Voco GmbH, from to . As of , FDA records show no recalls naming K080814.

Clearance record

Decision date
Received
(122 days to decision)
Product code
LBH Varnish, Cavity
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Voco GmbH Anton-Flettner-Strasse 1-3, Cuxhaven, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBH

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