510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910090Substantially Equivalent

Dimac Wires

Instrumentations Unltd., Quakertown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910090 is the FDA 510(k) clearance record for DIMAC WIRES, a class II device, cleared for Instrumentations Unltd. on under FDA product code DYX (Lock, Wire, And Ligature, Intraoral). FDA records list 2 510(k) clearances for Instrumentations Unltd., from to . As of , FDA records show no recalls naming K910090.

Clearance record

Decision date
Received
(197 days to decision)
Product code
DYX Lock, Wire, And Ligature, Intraoral
Regulation
21 CFR 872.4600
Device class
Class II
Review panel
Dental
Applicant
Instrumentations Unltd. 108 James St., Quakertown PA
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