Cleared Traditional

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

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

K201785 is an FDA 510(k) clearance for the EPIEN Dental Cleanser. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Epien Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 9, 2021 after a review of 436 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Epien Medical, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 127d · This submission: 436d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Consultant

The Allis Law Firm, Pllc
Carmelina G. Allis

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.