510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K851386Substantially Equivalent

Unitek Disposable Impression Syringe

Unitek Corp., Monrovia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851386 is the FDA 510(k) clearance record for UNITEK DISPOSABLE IMPRESSION SYRINGE, a class I device, cleared for Unitek Corp. on under FDA product code EID (Syringe, Restorative And Impression Material). FDA records list 23 510(k) clearances for Unitek Corp., from to . As of , FDA records show no recalls naming K851386.

Clearance record

Decision date
Received
(20 days to decision)
Product code
EID Syringe, Restorative And Impression Material
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Unitek Corp. 2724 S. Peck Rd., Monrovia CA
Third party review
No

Clearances, product code EID

Trailing 12 months

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

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