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510(k) K943486

ORAFIX SPECIAL DENTURE ADHESIVE by Smithkline Beecham Corp. — Product Code KOO

K943486 is an FDA 510(k) premarket notification submitted by Smithkline Beecham Corp. for the device "ORAFIX SPECIAL DENTURE ADHESIVE". The FDA issued a decision of Substantially Equivalent on November 3, 1994. The device falls under product code KOO (Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt), a Class I device regulated under 21 CFR 872.3490.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1994
Date Received
July 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
Device Class
Class I
Regulation Number
872.3490
Review Panel
DE
Submission Type

Other clearances for product code KOO

  • K945200 — FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES (November 30, 1994)
  • K930335 — PROFAST - DENTURE ADHESIVE FOR LOWER JAWS (February 1, 1994)
  • K862876 — NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM (August 29, 1986)

FDA data resources