EPIEN Dental Cleanser— 510(k) K201785

Name: FDA 510(k) clearance K201785
Creator: U.S. Food and Drug Administration
Published: 2021-09-09

Substantially Equivalent

Epien Medical, Inc.

FDA 510(k) clearance K201785 for EPIEN Dental Cleanser, Substantially Equivalent on 2021-09-09. Applicant: Epien Medical, Inc.. Device class: Unclassified.

Clearance details

Applicant: Epien Medical, Inc.
Product code: Code KJJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2020-06-30
Decision date: 2021-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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