510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K841003Substantially Equivalent

Probes, Various

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

K841003 is the FDA 510(k) clearance record for PROBES, VARIOUS, a class I device, cleared for Premier Dental Products Co. on under FDA product code KOA (Surgical Instruments, G-U, Manual (And Accessories)). FDA records list 44 510(k) clearances for Premier Dental Products Co., from to . As of , FDA records show no recalls naming K841003.

Clearance record

Decision date
Received
(11 days to decision)
Product code
KOA Surgical Instruments, G-U, Manual (And Accessories)
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Premier Dental Products Co. 1710 Romano Dr., Norristown PA
Third party review
No

Clearances, product code KOA

Trailing 12 months

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

FDA records show no clearances under product code KOA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KOA, 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