# K222142: BR SLA Type Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Biotem Co., Ltd.
- Decided: Jun 24, 2023 after 339 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894595 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171179: BR Type Implant System, Biotem Co., Ltd. (2018) Summary page 4.

## Indications for use
BR SLA Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. BR SLA Type Implant System is for single and two-stage surgical procedures. It is intended for delayed loading.

Source page: https://510kreport.com/device/K222142
Methodology: https://510kreport.com/methodology