Cleared Traditional

K943486 - ORAFIX SPECIAL DENTURE ADHESIVE
(FDA 510(k) Clearance)

K943486 · Smithkline Beecham Corp. · Dental

Nov 1994

Decision

107d

Days

Class 1

Risk

K943486 is an FDA 510(k) clearance for the ORAFIX SPECIAL DENTURE ADHESIVE, a Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt (Class I — General Controls, product code KOO), submitted by Smithkline Beecham Corp. (Parsippany, US). The FDA issued a Cleared decision on November 3, 1994, 107 days after receiving the submission on July 19, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.3490.

Submission Details

510(k) Number	K943486 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 1994
Decision Date	November 03, 1994
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement

Device Classification

Product Code	KOO — Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt
Device Class	Class I — General Controls
CFR Regulation	21 CFR 872.3490