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FDA 510(k)

PROFAST(R)-DENTURE ADHESIVE CREAM

K-Number: K930336 · 1993-08-24

ApplicantFittydent-Altwirth & Schmitt GmbH
Decision Date1993-08-24
Product CodeKGB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PROFAST(R)-DENTURE ADHESIVE CREAM 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 1993-08-24 under 510(k) number K930336. The device is classified under product code KGB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFAST(R)-DENTURE ADHESIVE CREAM?

PROFAST(R)-DENTURE ADHESIVE CREAM is a medical device that received FDA 510(k) clearance on 1993-08-24. The listed applicant is Fittydent-Altwirth & Schmitt GmbH. The 510(k) number is K930336.

When did PROFAST(R)-DENTURE ADHESIVE CREAM receive FDA 510(k) clearance?

PROFAST(R)-DENTURE ADHESIVE CREAM received FDA 510(k) clearance on 1993-08-24, under 510(k) number K930336.

Who is the listed applicant for PROFAST(R)-DENTURE ADHESIVE CREAM?

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(R)-DENTURE ADHESIVE CREAM?

The FDA product code for PROFAST(R)-DENTURE ADHESIVE CREAM is KGB.

Related Clinical Trials

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.

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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.

K930335PROFAST - DENTURE ADHESIVE FOR LOWER JAWSK930337PROFAST(R)-DENTURE CLEANSER

Related Devices (Code: KGB)

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.

K970688POCKET RESCUECheen Houng Ent. Co. , Ltd.K960401ULTIMATE SEALHans Rudolph, Inc.K941336COMBO MASKGam Industries, Inc.K935917CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVESBd Becton Dickinson Vacutainer Systems PreanalyticK932347COMPACT MASKVital Signs, Inc.K933583NONREBREATHING VALVEHans Rudolph, 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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