510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854088Substantially Equivalent

Unitek Lift-Off Debracketing Instrument

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

K854088 is the FDA 510(k) clearance record for UNITEK LIFT-OFF DEBRACKETING INSTRUMENT, a class I device, cleared for Unitex Corp. on under FDA product code JEX (Plier, Orthodontic). FDA records list one 510(k) clearance for Unitex Corp. As of , FDA records show no recalls naming K854088.

Clearance record

Decision date
Received
(50 days to decision)
Product code
JEX Plier, Orthodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Unitex Corp. 2724 S. Peck Rd., Monrovia CA
Third party review
No

Clearances, product code JEX

Trailing 12 months

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

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