The following data is part of a premarket notification filed by Materialise Dental Nv with the FDA for Simplant Ortho ; Vistadent 3d.
| Device ID | K081402 |
| 510k Number | K081402 |
| Device Name: | SIMPLANT ORTHO ; VISTADENT 3D |
| Classification | System, Image Processing, Radiological |
| Applicant | MATERIALISE DENTAL NV TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Contact | Carl Van Lierde |
| Correspondent | Carl Van Lierde MATERIALISE DENTAL NV TECHNOLOGIELAAN 15 Leuven, BE 3001 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-19 |
| Decision Date | 2008-07-18 |
| Summary: | summary |