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FDA 510(k)

EPIEN Dental Cleanser

K-Number: K201785 · 2021-09-09

ApplicantEpien Medical, Inc.
Decision Date2021-09-09
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

EPIEN Dental 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 2021-09-09 under 510(k) number K201785. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIEN Dental Cleanser?

EPIEN Dental Cleanser is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Epien Medical, Inc.. The 510(k) number is K201785.

When did EPIEN Dental Cleanser receive FDA 510(k) clearance?

EPIEN Dental Cleanser received FDA 510(k) clearance on 2021-09-09, under 510(k) number K201785.

Who is the listed applicant for EPIEN Dental 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 Dental Cleanser?

The FDA product code for EPIEN Dental Cleanser is KJJ.

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.K211813TritonInter-Med / Vista DentalK193357V-MixInter-Med/Vista Dental ProductsK193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental ProductsK200330RC-Prime Root Canal Preparation CreamPac-Dent, 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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