The following data is part of a premarket notification filed by Vita with the FDA for Vita Cad-temp For Inlab, Model, Vx59-4002, Vx59-4010, Vx59-4102, Vx59-4110, Vx59-4202, Vx59-4210, Vx59-4302, Vx59-4310.
| Device ID | K070991 |
| 510k Number | K070991 |
| Device Name: | VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | VITA 3150 E.BIRCH ST Brea, CA 92821 |
| Contact | Elizabeth Wolfsen |
| Correspondent | Elizabeth Wolfsen VITA 3150 E.BIRCH ST Brea, CA 92821 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-09 |
| Decision Date | 2007-06-01 |