CoDiagnostiX
Driver, Wire, And Bone Drill, Manual
Dental Wings GmbH
The following data is part of a premarket notification filed by Dental Wings Gmbh with the FDA for Codiagnostix.
Pre-market Notification Details
| Device ID | K193301 |
| 510k Number | K193301 |
| Device Name: | CoDiagnostiX |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | Dental Wings GmbH Duesseldorfer Platz 1 Chemnitz, DE 09111 |
| Contact | Angelika Hähnel |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-29 |
| Decision Date | 2021-06-21 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D835CODX200 | K193301 | 000 |
| 07630031755537 | K193301 | 000 |
Trademark Results [CoDiagnostiX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CODIAGNOSTIX 79098308 4173483 Live/Registered |
Straumann Holding AG 2011-04-29 |
 CODIAGNOSTIX 77263320 not registered Dead/Abandoned |
Anton Josef Voitik 2007-08-24 |
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