510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812239Substantially Equivalent

Unitek Palatal Bar

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

K812239 is the FDA 510(k) clearance record for UNITEK PALATAL BAR, a class I device, cleared for Unitek Corp. on under FDA product code DYT (Maintainer, Space Preformed, Orthodontic). FDA records list 23 510(k) clearances for Unitek Corp., from to . As of , FDA records show no recalls naming K812239.

Clearance record

Decision date
Received
(41 days to decision)
Product code
DYT Maintainer, Space Preformed, Orthodontic
Regulation
21 CFR 872.5525
Device class
Class I
Review panel
Dental
Applicant
Unitek Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DYT

Trailing 12 months

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

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