510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012761Substantially Equivalent

Prime-Dent Visible Light Cure Pit & Fissure Sealant

Prime Dental Manufacturing, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012761 is the FDA 510(k) clearance record for PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT, a class II device, cleared for Prime Dental Manufacturing, Inc. on under FDA product code EBC (Sealant, Pit And Fissure, And Conditioner). FDA records list 9 510(k) clearances for Prime Dental Manufacturing, Inc., from to . As of , FDA records show no recalls naming K012761.

Clearance record

Decision date
Received
(76 days to decision)
Product code
EBC Sealant, Pit And Fissure, And Conditioner
Regulation
21 CFR 872.3765
Device class
Class II
Review panel
Dental
Applicant
Prime Dental Manufacturing, Inc. 3735 W. Belmont Ave., Chicago IL
510(k) summary
Statement
Third party review
No

Clearances, product code EBC

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