510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820944Substantially Equivalent

Dental Arch Bar

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

K820944 is the FDA 510(k) clearance record for DENTAL ARCH BAR, a class II device, cleared for Unisplint Corp. on under FDA product code DYX (Lock, Wire, And Ligature, Intraoral). FDA records list 2 510(k) clearances for Unisplint Corp., from to . As of , FDA records show no recalls naming K820944.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DYX Lock, Wire, And Ligature, Intraoral
Regulation
21 CFR 872.4600
Device class
Class II
Review panel
Dental
Applicant
Unisplint Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DYX

Trailing 12 months

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

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