Cleared Traditional

K130180 - CLEANSER ROOT CANAL

K130180 · Cerkamed Wojciech Pawlowski · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
251d
Days
-
Risk

K130180 is an FDA 510(k) clearance for the CLEANSER ROOT CANAL. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Cerkamed Wojciech Pawlowski (Stalowa Wola, Podkarpacie, PL). The FDA issued a Cleared decision on October 3, 2013 after a review of 251 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K130180

510(k) Number K130180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2013
Decision Date October 03, 2013
Days to Decision 251 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
123d slower than avg
Panel avg: 128d · This submission: 251d
Pathway characteristics
Predicate-based equivalence.

KJJ Device Classification - Class 0,

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Peers - KJJ Cleanser, Root Canal

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K130180 · CLEANSER ROOT CANAL
Download PDF FDA Summary Cerkamed Wojciech Paw…