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 |