510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K130180Substantially Equivalent

Cleanser Root Canal

Cerkamed Wojciech Pawlowski, Stalowa Wola, Podkarpacie, PL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130180 is the FDA 510(k) clearance record for CLEANSER ROOT CANAL, cleared for Cerkamed Wojciech Pawlowski on under FDA product code KJJ (Cleanser, Root Canal). FDA records list one 510(k) clearance for Cerkamed Wojciech Pawlowski. As of , FDA records show no recalls naming K130180.

Clearance record

Decision date
Received
(251 days to decision)
Product code
KJJ Cleanser, Root Canal
Device class
Unclassified
Review panel
Unknown
Applicant
Cerkamed Wojciech Pawlowski Kwiatkowskiego 1 St., Stalowa Wola, Podkarpacie, PL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KJJ

Trailing 12 months

FDA records hold no clearances under product code KJJ in the trailing twelve months.

FDA records show no clearances under product code KJJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KJJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260