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
K842295Substantially Equivalent

Intrauterine Device Remover

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

K842295 is the FDA 510(k) clearance record for INTRAUTERINE DEVICE REMOVER, a class I device, cleared for Premier Dental Products Co. on under FDA product code HHF (Remover, Intrauterine Device, Contraceptive, Hook-Type). FDA records list 44 510(k) clearances for Premier Dental Products Co., from to . As of , FDA records show no recalls naming K842295.

Clearance record

Decision date
Received
(123 days to decision)
Product code
HHF Remover, Intrauterine Device, Contraceptive, Hook-Type
Regulation
21 CFR 884.4530
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Premier Dental Products Co. P.O. Box 111, Norristown PA
Third party review
No

Clearances, product code HHF

Trailing 12 months

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

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