510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K141352Substantially Equivalent

Endocyn Root Canal Irrigation Solution

Sonoma Pharmaceuticals, Inc., Petaluma CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141352 is the FDA 510(k) clearance record for ENDOCYN ROOT CANAL IRRIGATION SOLUTION, cleared for Oculus Innovative Sciences on under FDA product code KJJ (Cleanser, Root Canal). FDA records list 24 510(k) clearances for Sonoma Pharmaceuticals, Inc., from to . As of , FDA records show no recalls naming K141352.

Clearance record

Decision date
Received
(87 days to decision)
Product code
KJJ Cleanser, Root Canal
Device class
Unclassified
Review panel
Unknown
Applicant
Oculus Innovative Sciences 1129 N. Mcdowell Blvd., Petaluma CA
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