The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Telio Cad.
Device ID | K093708 |
510k Number | K093708 |
Device Name: | TELIO CAD |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Donna Mhartnett |
Correspondent | Donna Mhartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. 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 | 2009-12-02 |
Decision Date | 2010-03-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TELIO CAD 87441978 5667120 Live/Registered |
Ivoclar Vivadent, Inc. 2017-05-09 |