510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140349Substantially Equivalent

Starbright 5% Sodium Fluoride Varnish

Nanova Biomaterials Inc, Columbia MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140349 is the FDA 510(k) clearance record for STARBRIGHT 5% SODIUM FLUORIDE VARNISH, a class II device, cleared for Nanova Biomaterials, Inc. on under FDA product code LBH (Varnish, Cavity). FDA records list 8 510(k) clearances for Nanova Biomaterials, Inc., from to . As of , FDA records show no recalls naming K140349.

Clearance record

Decision date
Received
(215 days to decision)
Product code
LBH Varnish, Cavity
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Nanova Biomaterials, Inc. 3806 Mojave Ct., Columbia MO
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