510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904527Substantially Equivalent

Kapper

Senair-Mot, Orange CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904527 is the FDA 510(k) clearance record for KAPPER, a class II device, cleared for Senair-Mot on under FDA product code EJI (Syringe, Cartridge). FDA records list 2 510(k) clearances for Senair-Mot, from to . As of , FDA records show no recalls naming K904527.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EJI Syringe, Cartridge
Regulation
21 CFR 872.6770
Device class
Class II
Review panel
Dental
Applicant
Senair-Mot 1118 E Adams Ave., Orange CA
Third party review
No

Clearances, product code EJI

Trailing 12 months

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

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