510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950365Substantially Equivalent

Moyco-Edta

Union Broach, Div. Moyco Industries, Inc., Emigsville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950365 is the FDA 510(k) clearance record for MOYCO-EDTA, cleared for Union Broach, Div. Moyco Industries, Inc. on under FDA product code KJJ (Cleanser, Root Canal). FDA records list 14 510(k) clearances for Union Broach, Div. Moyco Industries, Inc., from to . As of , FDA records show no recalls naming K950365.

Clearance record

Decision date
Received
(86 days to decision)
Product code
KJJ Cleanser, Root Canal
Device class
Unclassified
Review panel
Unknown
Applicant
Union Broach, Div. Moyco Industries, Inc. Division Of Moyco Ind., Inc., Emigsville PA
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 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