The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Telio Cs Cem Implant.
Device ID | K120432 |
510k Number | K120432 |
Device Name: | TELIO CS CEM IMPLANT |
Classification | Cement, Dental |
Applicant | IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Donna Marie Hartnett |
Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-13 |
Decision Date | 2012-06-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TELIO CS CEM IMPLANT 85314524 not registered Dead/Abandoned |
Ivoclar Vivadent, Inc. 2011-05-06 |