The following data is part of a premarket notification filed by Exocad Gmbh with the FDA for Abutmentcad.
| Device ID | K193352 |
| 510k Number | K193352 |
| Device Name: | AbutmentCAD |
| Classification | Dental Abutment Design Software For Dental Laboratory |
| Applicant | exocad GmbH 37, Julius-Reiber-Str. Darmstadt, DE 64293 |
| Contact | Stefan Walter |
| Correspondent | Stefan Walter exocad GmbH 37, Julius-Reiber-Str. Darmstadt, DE 64293 |
| Product Code | PNP |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-04 |
| Decision Date | 2021-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260521363510 | K193352 | 000 |
| 04260521363527 | K193352 | 000 |
| 04260521363534 | K193352 | 000 |