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
K193301Substantially Equivalent

coDiagnostiX

Dental Wings GmbH, Chemnitz, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193301 is the FDA 510(k) clearance record for coDiagnostiX, a class II device, cleared for Dental Wings GmbH on under FDA product code DZJ (Driver, Wire, And Bone Drill, Manual). FDA records list one 510(k) clearance for Dental Wings GmbH. As of , FDA records show no recalls naming K193301.

Clearance record

Decision date
Received
(570 days to decision)
Product code
DZJ Driver, Wire, And Bone Drill, Manual
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Dental Wings GmbH Duesseldorfer Platz 1, Chemnitz, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZJ

Trailing 12 months
1 clearance under product code DZJ in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260