510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061997Substantially Equivalent

Premier Self-Etching Enamel Sealant

Premier Dental Products Co, Plymouth Meeting PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K061997 is the FDA 510(k) clearance record for PREMIER SELF-ETCHING ENAMEL SEALANT, a class II device, cleared for Premier Dental Products Co. on under FDA product code EBC (Sealant, Pit And Fissure, And Conditioner). FDA records list 44 510(k) clearances for Premier Dental Products Co., from to . As of , FDA records show no recalls naming K061997.

Clearance record

Decision date
Received
(82 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
Premier Dental Products Co. 1710 Romano Dr., Plymouth Meeting PA
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