510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912149Substantially Equivalent

Hardcoated Plastic Filling Instrument

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

K912149 is the FDA 510(k) clearance record for HARDCOATED PLASTIC FILLING INSTRUMENT, a class I device, cleared for Premier Dental Products Co. on under FDA product code EKJ (Burnisher, Operative). FDA records list 44 510(k) clearances for Premier Dental Products Co., from to . As of , FDA records show no recalls naming K912149.

Clearance record

Decision date
Received
(40 days to decision)
Product code
EKJ Burnisher, Operative
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Premier Dental Products Co. 1710 Romano Dr., Norristown PA
510(k) summary
Statement
Third party review
No

Clearances, product code EKJ

Trailing 12 months

FDA records hold no clearances under product code EKJ in the trailing twelve months.

FDA records show no clearances under product code EKJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EKJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260