510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K934415Substantially Equivalent

File-Eze

Ultradent Products Inc., Lake Oswego OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934415 is the FDA 510(k) clearance record for FILE-EZE, cleared for Ultradent Products, Inc. on under FDA product code KJJ (Cleanser, Root Canal). FDA records list 104 510(k) clearances for Ultradent Products, Inc., from to . As of , FDA records show no recalls naming K934415.

Clearance record

Decision date
Received
(215 days to decision)
Product code
KJJ Cleanser, Root Canal
Device class
Unclassified
Review panel
Unknown
Applicant
Ultradent Products, Inc. 2057 Summit Dr., Lake Oswego OR
510(k) summary
Statement
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KJJ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260