The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Telio Cad.
| Device ID | K093708 |
| 510k Number | K093708 |
| Device Name: | TELIO CAD |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Mhartnett |
| Correspondent | Donna Mhartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-02 |
| Decision Date | 2010-03-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TELIO CAD 87441978 5667120 Live/Registered |
Ivoclar Vivadent, Inc. 2017-05-09 |