# K232271: SIMDA abutment

- Pathway: 510(k) (Traditional)
- Applicant: Simda Co., Ltd.
- Decided: Oct 26, 2023 after 87 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: 16 generations back to K894844 (1990). 173 ancestors in all.
No later device cites it as a predicate yet.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223663: SIMDA Abutment, Simda Co., Ltd. (2023) Summary page 5.

## Indications for use
SIMDA 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. It is compatible with the following systems: All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture.

Source page: https://510kreport.com/device/K232271
Methodology: https://510kreport.com/methodology