The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Teliocad Multi.
| Device ID | K153753 |
| 510k Number | K153753 |
| Device Name: | TelioCAD Multi |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE Amherst, NY 14228 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE 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 | 2015-12-29 |
| Decision Date | 2016-04-12 |
| Summary: | summary |