EPIEN ROOT CANAL CLEANSER— 510(k) K123538

Name: FDA 510(k) clearance K123538
Creator: U.S. Food and Drug Administration
Published: 2013-02-01

Substantially Equivalent

Epien Medical, Inc.

FDA 510(k) clearance K123538 for EPIEN ROOT CANAL CLEANSER, Substantially Equivalent on 2013-02-01. 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: 2012-11-16
Decision date: 2013-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KJJ

view all

K250279 — RC-SwiftPrep2025-07-02
K241354 — Sealer Solvent2024-08-27
K201785 — EPIEN Dental Cleanser2021-09-09
K211813 — Triton2021-08-18
K193357 — V-Mix2020-10-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.