Cleared Traditional

K141352 - ENDOCYN ROOT CANAL IRRIGATION SOLUTION

K141352 · Oculus Innovative Sciences · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
87d
Days
-
Risk

K141352 is an FDA 510(k) clearance for the ENDOCYN ROOT CANAL IRRIGATION SOLUTION. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Oculus Innovative Sciences (Petaluma, US). The FDA issued a Cleared decision on August 18, 2014 after a review of 87 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.

FDA 510(k) Submission Details - K141352

510(k) Number K141352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2014
Decision Date August 18, 2014
Days to Decision 87 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
41d faster than avg
Panel avg: 128d · This submission: 87d
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 36
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