# K210354: SNUCONE Bone Level Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Snucone Co., Ltd.
- Decided: Jul 13, 2022 after 520 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: 11 generations back to K894595 (1990). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181138: IS-III active System, Neobiotech Co., Ltd. (2018) Summary page 4.

## Indications for use
SNUCONE Bone Level 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 bridge work. SNUCONE Bone Level 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.

Source page: https://510kreport.com/device/K210354
Methodology: https://510kreport.com/methodology