# K250280: SD TL Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Arum Dentistry Co., Ltd.
- Decided: Jul 23, 2025 after 173 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: 15 generations back to K894595 (1990). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242753: SD TL Implant System, Arum Dentistry Co., Ltd. (2025) Summary page 5.
- K213506: NB 1 SA Implant System, Arum Dentistry Co., Ltd. (2022) Summary page 5.
- K212702: IM/ST Fixture System, Guilin Fiteeth Medical Instrument Co., Ltd. (2022) Summary page 5.

## Indications for use
The SD TL 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. Abutments are indicated for screw-retained single restorations or cement-retained single of multi-unit restorations. SD TL Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. All digitally-designed abutments are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.

Source page: https://510kreport.com/device/K250280
Methodology: https://510kreport.com/methodology