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FDA 510(k)

PROFAST(R)-DENTURE CLEANSER

K-Number: K930337 · 1993-09-07

ApplicantFittydent-Altwirth & Schmitt GmbH
Decision Date1993-09-07
Product CodeEFT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROFAST(R)-DENTURE CLEANSER 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 1993-09-07 under 510(k) number K930337. The device is classified under product code EFT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFAST(R)-DENTURE CLEANSER?

PROFAST(R)-DENTURE CLEANSER is a medical device that received FDA 510(k) clearance on 1993-09-07. The listed applicant is Fittydent-Altwirth & Schmitt GmbH. The 510(k) number is K930337.

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

PROFAST(R)-DENTURE CLEANSER received FDA 510(k) clearance on 1993-09-07, under 510(k) number K930337.

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

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 CLEANSER?

The FDA product code for PROFAST(R)-DENTURE CLEANSER is EFT.

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 JAWSK930336PROFAST(R)-DENTURE ADHESIVE CREAM

Related Devices (Code: EFT)

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.

K080631CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSEROral Health Technologies, LLCK051342MEDICAL INTERPOROUSBonyf AGK000996TRUBYTE DENTURE CLEANSER/POLISHING COMPOUNDDentsply Intl.K942203OTC DENTURE CLEANSERCombe, Inc.K914257DENTURE PRODUCT XEssential Dental Systems, Inc.K925259CFR MONOGRAPHCombe, 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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