# K180564: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases

- Pathway: 510(k) (Traditional)
- Applicant: Medentika GmbH
- Decided: Jan 7, 2019 after 308 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K894844 (1990). 261 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 264 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170838: Medentika CAD/CAM TiBases, Medentika GmbH (2017) Summary page 6.
- K150203: Medentika CAD/CAM Abutments, Medentika GmbH (2015) Summary page 6.
- K142167: Medentika Abutment System, Medentika GmbH (2015) Summary page 6.

## Most influential descendants
- K191111: DD Solid Connect® CAD/CAM Abutments (2023), 1 descendant of its own
- K230218: DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) (2023), 0 descendants of its own

## Indications for use
Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Abutments are compatible with the following implant systems: Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika PreFace is intended for use with the Straumann CARES System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann CARES validated milling center. Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika TiBase is intended for use with the Straumann CARES System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center.

Source page: https://510kreport.com/device/K180564
Methodology: https://510kreport.com/methodology