The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Telio Cad Abutment Solutions.
| Device ID | K151564 |
| 510k Number | K151564 |
| Device Name: | Telio CAD Abutment Solutions |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | IVOCLAR VIVADENT AG BENDERERSTRASSE 2 Schaan, LI 9494 |
| Contact | Sandra Cakebread |
| Correspondent | Donna Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE Amherst, NY 14228 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-10 |
| Decision Date | 2015-09-21 |
| Summary: | summary |