510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943486Substantially Equivalent

Orafix Special Denture Adhesive

Smithkline Beecham Corp., Parsippany NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943486 is the FDA 510(k) clearance record for ORAFIX SPECIAL DENTURE ADHESIVE, a class I device, cleared for Smithkline Beecham Corp. on under FDA product code KOO (Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt). FDA records list one 510(k) clearance for Smithkline Beecham Corp. As of , FDA records show no recalls naming K943486.

Clearance record

Decision date
Received
(107 days to decision)
Product code
KOO Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
Regulation
21 CFR 872.3490
Device class
Class I
Review panel
Dental
Applicant
Smithkline Beecham Corp. 1500 Littleton Rd., Parsippany NJ
510(k) summary
Statement
Third party review
No

Clearances, product code KOO

Trailing 12 months

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

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