510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903007Substantially Equivalent

Mircas Dental Cartridge Syringe and Mircas Cover

Habley Medical Technology Corp., Laguana Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903007 is the FDA 510(k) clearance record for MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER, a class II device, cleared for Habley Medical Technology Corp. on under FDA product code EJI (Syringe, Cartridge). FDA records list 5 510(k) clearances for Habley Medical Technology Corp., from to . As of , FDA records show no recalls naming K903007.

Clearance record

Decision date
Received
(70 days to decision)
Product code
EJI Syringe, Cartridge
Regulation
21 CFR 872.6770
Device class
Class II
Review panel
Dental
Applicant
Habley Medical Technology Corp. 22982 Alcalde Dr., Laguana Hills 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