# K982509: Ortho Implant and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Sep 30, 1998 after 72 days
- Product code: OAT (Implant, Endosseous, Orthodontic)
- 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: 2 generations back to K894844 (1990). 12 ancestors in all.
66 later devices descend from it; 6 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971578: Endosseous Dental Implant, Straumann USA (1997) Summary page 1.
- K973353: Bonding Base, Straumann USA (1997) Summary page 1.
- K980460: Onplant Orthodontic System, Nobel Biocare Uas, Inc. (1998) Summary page 1.
- K972351: Sendax Mdi (Mini Dental Implant), Sendax Mdic Management, Inc. (1997) Summary page 1.

## Most influential descendants
- K031936: Osteomed Orthodontic Screw System (2004), 63 descendants of its own
- K033767: Dual Top Anchor System Screws (2004), 54 descendants of its own
- K042965: Tomas Pin (2005), 26 descendants of its own
- K060126: Absoanchor Microimplant (2006), 19 descendants of its own
- K071490: Leone Orthodontic Mini Implant (2008), 14 descendants of its own

## Indications for use
The Ortho implant of the Straumann Orthosystem is an endosseous implant intended for placement in the median palatal region or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.

Source page: https://510kreport.com/device/K982509
Methodology: https://510kreport.com/methodology