The following data is part of a premarket notification filed by Durr Dental Se with the FDA for Provecta 3d Prime Ceph.
| Device ID | K193139 |
| 510k Number | K193139 |
| Device Name: | ProVecta 3D Prime Ceph |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | Durr Dental SE Hopfigheimer Str. 17 Bietigheim-bissingen, DE 74321 |
| Contact | Oliver Lange |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-13 |
| Decision Date | 2020-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E2472210200729 | K193139 | 000 |
| E247A78500 | K193139 | 000 |
| E247A78610 | K193139 | 000 |