510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111465Substantially Equivalent

Compothixo

Kerrhawe SA, Orange CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111465 is the FDA 510(k) clearance record for COMPOTHIXO, a class I device, cleared for Kerrhawe SA on under FDA product code DZN (Instruments, Dental Hand). FDA records list one 510(k) clearance for Kerrhawe SA. As of , FDA records show no recalls naming K111465.

Clearance record

Decision date
Received
(426 days to decision)
Product code
DZN Instruments, Dental Hand
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Kerrhawe SA 1717 W. Collins Ave., Orange CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZN

Trailing 12 months

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

FDA records show no clearances under product code DZN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DZN, 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