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FDA 510(k)

EPIEN ROOT CANAL CLEANSER

K-Number: K123538 · 2013-02-01

ApplicantEpien Medical, Inc.
Decision Date2013-02-01
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

EPIEN ROOT CANAL CLEANSER is the device name listed in this FDA 510(k) record. The listed applicant is Epien Medical, Inc.. It received FDA 510(k) clearance on 2013-02-01 under 510(k) number K123538. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIEN ROOT CANAL CLEANSER?

EPIEN ROOT CANAL CLEANSER is a medical device that received FDA 510(k) clearance on 2013-02-01. The listed applicant is Epien Medical, Inc.. The 510(k) number is K123538.

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

EPIEN ROOT CANAL CLEANSER received FDA 510(k) clearance on 2013-02-01, under 510(k) number K123538.

Who is the listed applicant for EPIEN ROOT CANAL CLEANSER?

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

What is the FDA product code for EPIEN ROOT CANAL CLEANSER?

The FDA product code for EPIEN ROOT CANAL CLEANSER is KJJ.

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 Epien Medical, Inc. 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.

K201785EPIEN Dental Cleanser

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

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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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