# K241703: SD Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Arum Dentistry Co., Ltd.
- Decided: Feb 24, 2025 after 256 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: 12 generations back to K894595 (1990). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213506: NB 1 SA Implant System, Arum Dentistry Co., Ltd. (2022) Summary page 5.

## Indications for use
The SD Implant System is indicated for use in partially or fully edentulous mandibular and maxillary areas, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. SD Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions. The multi-unit abutments are designed for use in multi-unit restorations. They should be used in cases where multiple implants are placed to support a prosthetic dental restoration not suitable for single-unit restorations. All digitally designed abutments for use with Customized Abutment are intended to be manufactured at an ARUM DENTISTRY validated milling center. Smaller diameter implant bodies (i.e., 3.3mm and 3.7mm) are indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions.

Source page: https://510kreport.com/device/K241703
Methodology: https://510kreport.com/methodology