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 |