510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K890043Substantially Equivalent

Dentclean Concentrated Denture Cleanser

K-P Co., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890043 is the FDA 510(k) clearance record for DENTCLEAN CONCENTRATED DENTURE CLEANSER, a class I device, cleared for K-P Co. on under FDA product code EFT (Cleanser, Denture, Over The Counter). FDA records list one 510(k) clearance for K-P Co. As of , FDA records show no recalls naming K890043.

Clearance record

Decision date
Received
(153 days to decision)
Product code
EFT Cleanser, Denture, Over The Counter
Regulation
21 CFR 872.3520
Device class
Class I
Review panel
Dental
Applicant
K-P Co. 4857 Delhi Rd., Cincinnati OH
Third party review
No

Clearances, product code EFT

Trailing 12 months

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

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