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FDA 510(k)

ORAFIX SPECIAL DENTURE ADHESIVE

K-Number: K943486 · 1994-11-03

ApplicantSmithkline Beecham Corp.
Decision Date1994-11-03
Product CodeKOO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORAFIX SPECIAL DENTURE ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Beecham Corp.. It received FDA 510(k) clearance on 1994-11-03 under 510(k) number K943486. The device is classified under product code KOO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAFIX SPECIAL DENTURE ADHESIVE?

ORAFIX SPECIAL DENTURE ADHESIVE is a medical device that received FDA 510(k) clearance on 1994-11-03. The listed applicant is Smithkline Beecham Corp.. The 510(k) number is K943486.

When did ORAFIX SPECIAL DENTURE ADHESIVE receive FDA 510(k) clearance?

ORAFIX SPECIAL DENTURE ADHESIVE received FDA 510(k) clearance on 1994-11-03, under 510(k) number K943486.

Who is the listed applicant for ORAFIX SPECIAL DENTURE ADHESIVE?

The FDA 510(k) record lists Smithkline Beecham Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORAFIX SPECIAL DENTURE ADHESIVE?

The FDA product code for ORAFIX SPECIAL DENTURE ADHESIVE is KOO.

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Related Devices (Code: KOO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K945200FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCESProcter & Gamble Co.K930335PROFAST - DENTURE ADHESIVE FOR LOWER JAWSFittydent-Altwirth & Schmitt GmbHK862876NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAMBlock Drug Company, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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