The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Telio Cs Cem Implant.
| Device ID | K120432 |
| 510k Number | K120432 |
| Device Name: | TELIO CS CEM IMPLANT |
| Classification | Cement, Dental |
| Applicant | IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-13 |
| Decision Date | 2012-06-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TELIO CS CEM IMPLANT 85314524 not registered Dead/Abandoned |
Ivoclar Vivadent, Inc. 2011-05-06 |