# K221972: Warantec Custom Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Warantec Co., Ltd.
- Decided: Oct 2, 2023 after 454 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: 17 generations back to K894844 (1990). 223 ancestors in all.
No later device cites it as a predicate yet.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110308: Prosthetic System, Osstem Implant Co., Ltd. (2011) Summary page 5.
- K161713: Dentium CAD/CAM Abutments, Dentium Co., Ltd. (2016) Summary page 5.
- K192457: Elos Accurate Customized Abutment, Elos Medtech Pinol A/S (2020) Summary page 5.
- K172345: IU Implant System, Warantec Co., Ltd. (2018) Summary page 5.

## Indications for use
The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. All digitally designed abutments for use with Warantec Custom Abutments are intended to be sent to a Warantec-validated milling center for manufacture.

Source page: https://510kreport.com/device/K221972
Methodology: https://510kreport.com/methodology