510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854430Substantially Equivalent

Rigident Cream

Armkel, LLC, Cranbury NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854430 is the FDA 510(k) clearance record for RIGIDENT CREAM, a class I device, cleared for Armkel, LLC on under FDA product code KOT (Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium). FDA records list 68 510(k) clearances for Armkel, LLC, from to . As of , FDA records show no recalls naming K854430.

Clearance record

Decision date
Received
(119 days to decision)
Product code
KOT Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
Regulation
21 CFR 872.3490
Device class
Class I
Review panel
Dental
Applicant
Armkel, LLC Half Acre Rd., Cranbury NJ
Third party review
No

Clearances, product code KOT

Trailing 12 months

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

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