510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K871785Substantially Equivalent

Denture Cleansing Tablet

Pennex Products Co., Inc., Verona PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871785 is the FDA 510(k) clearance record for DENTURE CLEANSING TABLET, a class I device, cleared for Pennex Products Co., Inc. on under FDA product code EFT (Cleanser, Denture, Over The Counter). FDA records list one 510(k) clearance for Pennex Products Co., Inc. As of , FDA records show no recalls naming K871785.

Clearance record

Decision date
Received
(128 days to decision)
Product code
EFT Cleanser, Denture, Over The Counter
Regulation
21 CFR 872.3520
Device class
Class I
Review panel
Dental
Applicant
Pennex Products Co., Inc. Eastern Ave. At Pennex Dr., Verona PA
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