# K242542: Medentika CAD/CAM Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Medentika GmbH
- Decided: Apr 22, 2025 after 239 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: 21 generations back to K960026 (1996). 334 ancestors in all.
No later device cites it as a predicate yet.
0 of 335 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221301: DESS Dental Smart Solutions, Terrats Medical SL (2023) Summary page 6.
- K170838: Medentika CAD/CAM TiBases, Medentika GmbH (2017) Summary page 6.
- K223113: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments, Medentika GmbH (2024) Summary page 6.
- K150203: Medentika CAD/CAM Abutments, Medentika GmbH (2015) Summary page 6.

## Indications for use
PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, and Titanium base ASC Flex are intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. Abutment-level prosthetic components (Multi-unit Titanium Base, Multi-unit Titanium Cap, MedentiBASE Titanium Base) are intended for use as a support for multi-unit screw-retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient. All digitally designed abutments for use with PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, Titanium base ASC Flex, Multi-unit Titanium Base, Multi-unit Titanium Cap, and MedentiBASE Titanium Base are intended to be sent to an FDA-registered Medentika validated milling center for manufacture or to be manufactured according to the digital dentistry workflow, which integrates multiple components: Scans from desktop and intra oral scanners, CAD and CAM software and milling machine with associated accessories. Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

Source page: https://510kreport.com/device/K242542
Methodology: https://510kreport.com/methodology