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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 a medical device manufactured by Epien Medical, Inc.. It received FDA 510(k) clearance on 2021-09-09 under approval 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. It is manufactured by Epien Medical, Inc.. The 510(k) number is K201785.

When was EPIEN Dental Cleanser approved by the FDA?

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

What company makes EPIEN Dental Cleanser?

EPIEN Dental Cleanser is manufactured by Epien Medical, Inc..

What is the FDA product code for EPIEN Dental Cleanser?

The FDA product code for EPIEN Dental Cleanser is KJJ.

Related Devices (Code: KJJ)

K160577PacEndo ChlorhexidinePac-Dent International, Inc. K153528PacEndo EDTAPac-Dent International, Inc. K162311Straumann PrefGelInstitut Straumann AG K173163ChlorCid, ChlorCid V, ChlorCid SurfUltradent Products, Inc. K193357V-MixInter-Med/Vista Dental Products K193409Vista 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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