510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950309Substantially Equivalent

Eagle

Aalba Dent, Inc., Fairfield CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950309 is the FDA 510(k) clearance record for EAGLE, a class II device, cleared for Aalba Dent, Inc. on under FDA product code EJI (Syringe, Cartridge). FDA records list 27 510(k) clearances for Aalba Dent, Inc., from to . As of , FDA records show no recalls naming K950309.

Clearance record

Decision date
Received
(22 days to decision)
Product code
EJI Syringe, Cartridge
Regulation
21 CFR 872.6770
Device class
Class II
Review panel
Dental
Applicant
Aalba Dent, Inc. 400 Watt Dr., Fairfield CA
510(k) summary
Statement
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