# K222144: IR SLA Type Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Biotem Co., Ltd.
- Decided: Jun 14, 2023 after 329 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)
- K171185: IR Type Implant System, Biotem Co., Ltd. (2017) Summary page 4.

## Indications for use
IR 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. IR SLA Type Implant System is for one stage surgical procedures. It is intended for delayed loading. IR SLA Type Implant System is intended only for straight placement with no correction of angulation.

Source page: https://510kreport.com/device/K222144
Methodology: https://510kreport.com/methodology