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FDA 510(k)

CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER

K-Number: K080631 · 2008-05-23

ApplicantOral Health Technologies, LLC
Decision Date2008-05-23
Product CodeEFT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER is the device name listed in this FDA 510(k) record. The listed applicant is Oral Health Technologies, LLC. It received FDA 510(k) clearance on 2008-05-23 under 510(k) number K080631. 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 CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER?

CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER is a medical device that received FDA 510(k) clearance on 2008-05-23. The listed applicant is Oral Health Technologies, LLC. The 510(k) number is K080631.

When did CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER receive FDA 510(k) clearance?

CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER received FDA 510(k) clearance on 2008-05-23, under 510(k) number K080631.

Who is the listed applicant for CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER?

The FDA 510(k) record lists Oral Health Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER?

The FDA product code for CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER is EFT.

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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.

K051342MEDICAL INTERPOROUSBonyf AGK000996TRUBYTE DENTURE CLEANSER/POLISHING COMPOUNDDentsply Intl.K942203OTC DENTURE CLEANSERCombe, Inc.K930337PROFAST(R)-DENTURE CLEANSERFittydent-Altwirth & Schmitt GmbHK914257DENTURE PRODUCT XEssential Dental Systems, Inc.K925259CFR MONOGRAPHCombe, 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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