# K220562: TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Megagen Implant Co., Ltd.
- Decided: Nov 10, 2022 after 255 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 K894844 (1990). 171 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150203: Medentika CAD/CAM Abutments, Medentika GmbH (2015) Summary page 4.

## Most influential descendants
- K223663: SIMDA Abutment (2023), 2 descendants of its own
- K252320: SIMDA Abutments (2025), 0 descendants of its own
- K240725: PreXolid CAD/CAM abutments (2024), 0 descendants of its own
- K234142: TiGEN Abutment, PMMA Abutment and Scan Healing Abutment (2024), 0 descendants of its own
- K232271: SIMDA abutment (2023), 0 descendants of its own

## Indications for use
The TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation. For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

Source page: https://510kreport.com/device/K220562
Methodology: https://510kreport.com/methodology