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FDA 510(k)

PROFAST - DENTURE ADHESIVE FOR LOWER JAWS

K-Number: K930335 · 1994-02-01

ApplicantFittydent-Altwirth & Schmitt GmbH
Decision Date1994-02-01
Product CodeKOO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROFAST - DENTURE ADHESIVE FOR LOWER JAWS is the device name listed in this FDA 510(k) record. The listed applicant is Fittydent-Altwirth & Schmitt GmbH. It received FDA 510(k) clearance on 1994-02-01 under 510(k) number K930335. 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 PROFAST - DENTURE ADHESIVE FOR LOWER JAWS?

PROFAST - DENTURE ADHESIVE FOR LOWER JAWS is a medical device that received FDA 510(k) clearance on 1994-02-01. The listed applicant is Fittydent-Altwirth & Schmitt GmbH. The 510(k) number is K930335.

When did PROFAST - DENTURE ADHESIVE FOR LOWER JAWS receive FDA 510(k) clearance?

PROFAST - DENTURE ADHESIVE FOR LOWER JAWS received FDA 510(k) clearance on 1994-02-01, under 510(k) number K930335.

Who is the listed applicant for PROFAST - DENTURE ADHESIVE FOR LOWER JAWS?

The FDA 510(k) record lists Fittydent-Altwirth & Schmitt GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROFAST - DENTURE ADHESIVE FOR LOWER JAWS?

The FDA product code for PROFAST - DENTURE ADHESIVE FOR LOWER JAWS is KOO.

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Other records listing Fittydent-Altwirth & Schmitt GmbH as applicant

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.

K930337PROFAST(R)-DENTURE CLEANSERK930336PROFAST(R)-DENTURE ADHESIVE CREAM

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.K943486ORAFIX SPECIAL DENTURE ADHESIVESmithkline Beecham Corp.K862876NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAMBlock Drug Company, Inc.

Official Source

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

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