# K080128: SM-Extra Wide (RBM) Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dio Department Dsi, Inc.
- Decided: May 14, 2008 after 118 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: 3 generations back to K010185 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063216: Rescue Internal Implant System, Megagen Co., Ltd. (2007) Summary page 1.

## Indications for use
SM-Extra Wide(RBM) Implant Fixture is intended to be surgically placed in the maxillary or mandivular molar areas for the purpose of providing prosthetic support for dental restoration (Crown, Bridges, and overdentures) in partially or fully edentulous individuals. These Fixtures can be used where smaller implants have failed.

Source page: https://510kreport.com/device/K080128
Methodology: https://510kreport.com/methodology