The following data is part of a premarket notification filed by Medentika Gmbh with the FDA for Medentika Cad/cam Tibases.
Device ID | K170838 |
510k Number | K170838 |
Device Name: | Medentika CAD/CAM TiBases |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Medentika GmbH AHammweg 8-10 Huegelsheim, DE 76549 |
Contact | Gerhard Polzer |
Correspondent | Jennifer M. Jackson Straumann USA, LLC 60-100 Minuteman Rd Andover, MA 01810 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-21 |
Decision Date | 2017-09-15 |
Summary: | summary |