Cleared Traditional

K201785 - EPIEN Dental Cleanser (FDA 510(k) Clearance)

K201785 · Epien Medical, Inc. · Dental device
Sep 2021
Decision
436d
Days
-
Risk

K201785 is an FDA 510(k) clearance for the EPIEN Dental Cleanser. This device is classified as 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 FDA review panel.

Submission Details

510(k) Number K201785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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

Device Classification

Product Code KJJ - Cleanser, Root Canal
Device Class -