# K120951: Smartbuilder System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Oct 3, 2012 after 187 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894595 (1990). 28 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111761: Neo Titanium Mesh, Cti-Mem, Neobiotech Co., Ltd. (2012) Summary page 1.
- K090825: SQ IS System, Neobiotech Co., Ltd. (2009) Summary page 1.

## Most influential descendants
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K140600: SB Anchor (2014), 4 descendants of its own
- K172354: OssBuilder System (2018), 3 descendants of its own
- K231411: INNO SLA Submerged Hybrid Ti-Base System (2023), 1 descendant of its own
- K231395: INNO SLA Submerged Narrow Implant System (2023), 1 descendant of its own

## Indications for use
SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

Source page: https://510kreport.com/device/K120951
Methodology: https://510kreport.com/methodology