The following data is part of a premarket notification filed by Straumann Usa with the FDA for Codiagnostix Implant Planning Software.
| Device ID | K130724 |
| 510k Number | K130724 |
| Device Name: | CODIAGNOSTIX IMPLANT PLANNING SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | STRAUMANN USA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan STRAUMANN USA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-18 |
| Decision Date | 2013-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D835CDX202 | K130724 | 000 |