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FDA 510(k)

TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND

K-Number: K000996 · 2000-06-16

ApplicantDentsply Intl.
Decision Date2000-06-16
Product CodeEFT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2000-06-16 under 510(k) number K000996. 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 TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND?

TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND is a medical device that received FDA 510(k) clearance on 2000-06-16. The listed applicant is Dentsply Intl.. The 510(k) number is K000996.

When did TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND receive FDA 510(k) clearance?

TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND received FDA 510(k) clearance on 2000-06-16, under 510(k) number K000996.

Who is the listed applicant for TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND?

The FDA 510(k) record lists Dentsply Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND?

The FDA product code for TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND 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.

K080631CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSEROral Health Technologies, LLCK051342MEDICAL INTERPOROUSBonyf AGK942203OTC DENTURE CLEANSERCombe, Inc.K930337PROFAST(R)-DENTURE CLEANSERFittydent-Altwirth & Schmitt GmbHK914257DENTURE 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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