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FDA 510(k)

DENTURE CLEANSER

K-Number: K841801 · 1984-06-22

ApplicantMiracle Clean, Inc.
Decision Date1984-06-22
Product CodeEFT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTURE CLEANSER is the device name listed in this FDA 510(k) record. The listed applicant is Miracle Clean, Inc.. It received FDA 510(k) clearance on 1984-06-22 under 510(k) number K841801. 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 DENTURE CLEANSER?

DENTURE CLEANSER is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Miracle Clean, Inc.. The 510(k) number is K841801.

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

DENTURE CLEANSER received FDA 510(k) clearance on 1984-06-22, under 510(k) number K841801.

Who is the listed applicant for DENTURE CLEANSER?

The FDA 510(k) record lists Miracle Clean, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTURE CLEANSER?

The FDA product code for 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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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.K930337PROFAST(R)-DENTURE CLEANSERFittydent-Altwirth & Schmitt GmbHK914257DENTURE PRODUCT XEssential Dental Systems, 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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