Cleared Traditional

EPIEN Dental Cleanser

K201785 · Epien Medical, Inc. · Dental

Sep 2021

Decision

436d

Days

—

Risk

About This 510(k) Submission

K201785 is an FDA 510(k) clearance for the EPIEN Dental Cleanser, a Cleanser, Root Canal, submitted by Epien Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 9, 2021, 436 days after receiving the submission on June 30, 2020. This device falls under the Dental review panel.

Submission Details

510(k) Number	K201785 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2020
Decision Date	September 09, 2021
Days to Decision	436 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement