# K140600: SB Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Aug 21, 2014 after 164 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894595 (1990). 29 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120951: Smartbuilder System, Osstem Implant Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K172354: OssBuilder System (2018), 3 descendants of its own
- K222451: Save GBR (2023), 0 descendants of its own
- K192747: Yxoss CBR® (2020), 0 descendants of its own
- K181854: OssBuilder System (2019), 0 descendants 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/K140600
Methodology: https://510kreport.com/methodology