ORAFIX SPECIAL DENTURE ADHESIVE— 510(k) K943486

Name: FDA 510(k) clearance K943486
Creator: U.S. Food and Drug Administration
Published: 1994-11-03

Substantially Equivalent

Smithkline Beecham Corp.

FDA 510(k) clearance K943486 for ORAFIX SPECIAL DENTURE ADHESIVE, Substantially Equivalent on 1994-11-03. Applicant: Smithkline Beecham Corp.. Device class: 1.

Clearance details

Applicant: Smithkline Beecham Corp.
Product code: Code KOO
Device class: Class 1
Regulation: 21 CFR 872.3490
Advisory panel: Dental
Date received: 1994-07-19
Decision date: 1994-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOO

view all

K945200 — FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES1994-11-30
K930335 — PROFAST - DENTURE ADHESIVE FOR LOWER JAWS1994-02-01
K862876 — NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM1986-08-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.