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FDA 510(k)

BIOPURE MTAD ROOT CANAL CLEANSER

K-Number: K053167 · 2005-12-08

ApplicantDentsply Intl., Inc.
Decision Date2005-12-08
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

BIOPURE MTAD ROOT CANAL CLEANSER is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl., Inc.. It received FDA 510(k) clearance on 2005-12-08 under 510(k) number K053167. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPURE MTAD ROOT CANAL CLEANSER?

BIOPURE MTAD ROOT CANAL CLEANSER is a medical device that received FDA 510(k) clearance on 2005-12-08. The listed applicant is Dentsply Intl., Inc.. The 510(k) number is K053167.

When did BIOPURE MTAD ROOT CANAL CLEANSER receive FDA 510(k) clearance?

BIOPURE MTAD ROOT CANAL CLEANSER received FDA 510(k) clearance on 2005-12-08, under 510(k) number K053167.

Who is the listed applicant for BIOPURE MTAD ROOT CANAL CLEANSER?

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

What is the FDA product code for BIOPURE MTAD ROOT CANAL CLEANSER?

The FDA product code for BIOPURE MTAD ROOT CANAL CLEANSER is KJJ.

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Other records listing Dentsply Intl., Inc. as applicant

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Related Devices (Code: KJJ)

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.

K250279RC-SwiftPrepBelport Company, Inc., Gingi-PakK241354Sealer SolventInter-Med, Inc.K201785EPIEN Dental CleanserEpien Medical, Inc.K211813TritonInter-Med / Vista DentalK193357V-MixInter-Med/Vista Dental ProductsK193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products

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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