# K111287: Astra Tech Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech AB
- Decided: Sep 26, 2011 after 143 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: 9 generations back to K894595 (1990). 26 ancestors in all.
201 later devices descend from it; 3 cite it directly.
0 of 228 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101732: Astra Tech Implant System, Astra Tech AB (2011) Summary page 3.
- K091239: Astra Tech Implant System, Astra Tech AB (2009) Summary page 3.
- K053384: Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System, Astra Tech, Inc. (2006) Summary page 3.
- K083496: Camlog Implant System Modified Implants and Abutments, Altatec GmbH (2009) Summary page 3.

## Most influential descendants
- K112138: Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant (2011), 200 descendants of its own
- K120414: Osseospeed Plus (2012), 196 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K150295: LOCATOR RTx (2015), 42 descendants of its own

## Indications for use
OsseoSpeedTM Plus implants of the Astra Tech Implant System Plus are intended to be used: * To replace missing teeth in single or multiple unit applications within the mandible or maxilla * For immediate placement in extraction sites and partially or completely healed alveolar ridge situations * For both one- and two-stage surgical procedures " Especially well in soft bone applications where implants with other implant surface treatments may be less effective * Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. Astra Tech Implant System Plus abutments are intended to be used in conjunction with the Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

Source page: https://510kreport.com/device/K111287
Methodology: https://510kreport.com/methodology