510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973919Substantially Equivalent

Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)

Medental Intl., Evergreen CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973919 is the FDA 510(k) clearance record for CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL), a class II device, cleared for Medental Intl. on under FDA product code LBH (Varnish, Cavity). FDA records list 7 510(k) clearances for Medental Intl., from to . As of , FDA records show no recalls naming K973919.

Clearance record

Decision date
Received
(62 days to decision)
Product code
LBH Varnish, Cavity
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Medental Intl. 1246 Clear Creek Rd., Evergreen CO
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