The following data is part of a premarket notification filed by Instrumentarium Dental Inc. with the FDA for Volumetric Tomography.
| Device ID | K063773 |
| 510k Number | K063773 |
| Device Name: | VOLUMETRIC TOMOGRAPHY |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | INSTRUMENTARIUM DENTAL INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Contact | Frank Kashinski |
| Correspondent | Frank Kashinski INSTRUMENTARIUM DENTAL INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-21 |
| Decision Date | 2007-01-31 |
| Summary: | summary |