The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Silanit.
| Device ID | K802679 |
| 510k Number | K802679 |
| Device Name: | SILANIT |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | VIVADENT (USA), INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-28 |
| Decision Date | 1980-12-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SILANIT 90200102 not registered Live/Pending |
Chen Xiaojin 2020-09-22 |