Cleared Traditional

K123538 - EPIEN ROOT CANAL CLEANSER

K123538 · Epien Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
77d
Days
-
Risk

K123538 is an FDA 510(k) clearance for the EPIEN ROOT CANAL CLEANSER. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Epien Medical, Inc. (Washington, US). The FDA issued a Cleared decision on February 1, 2013 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Epien Medical, Inc. devices

FDA 510(k) Submission Details - K123538

510(k) Number K123538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2012
Decision Date February 01, 2013
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 128d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

KJJ Device Classification - Class 0,

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

All 35
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