# K253341: Custom Abutments AS

- Pathway: 510(k) (Traditional)
- Applicant: Medentika GmbH
- Decided: Dec 23, 2025 after 84 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: 14 generations back to K894595 (1990). 212 ancestors in all.
No later device cites it as a predicate yet.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223113: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments, Medentika GmbH (2024) Summary page 7.

## Indications for use
Medentika Custom Abutments AS (Angulated Screw Channel) 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. Medentika Custom Abutments AS are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments AS are intended to be manufactured at a Straumann® validated milling center. The final patient matched form is a Custom Abutment AS. 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, and Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

Source page: https://510kreport.com/device/K253341
Methodology: https://510kreport.com/methodology