# K223113: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Medentika GmbH
- Decided: Apr 15, 2024 after 560 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: 13 generations back to K894595 (1990). 211 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 215 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142167: Medentika Abutment System, Medentika GmbH (2015) Summary page 10.

## Most influential descendants
- K260460: Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue (2026), 0 descendants of its own
- K253341: Custom Abutments AS (2025), 0 descendants of its own
- K242542: Medentika CAD/CAM Abutments (2025), 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. Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. 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. Medentika abutments for the Nobel Biocare Nobel Active®* 3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV®* 3.0mm and TX®* 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. 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. The final patient matched form is a MedentiCAD abutment. Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.

Source page: https://510kreport.com/device/K223113
Methodology: https://510kreport.com/methodology