# K101732: Astra Tech Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech AB
- Decided: Feb 23, 2011 after 247 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: 8 generations back to K894595 (1990). 24 ancestors in all.
214 later devices descend from it; 11 cite it directly.
0 of 239 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 2.
- K091239: Astra Tech Implant System, Astra Tech AB (2009) Summary page 2.
- K053384: Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System, Astra Tech, Inc. (2006) Summary page 2.

## Most influential descendants
- K111287: Astra Tech Implant System (2011), 201 descendants of its own
- 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

## Indications for use
The OsseoSpeed implants 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 together with immediate loading protocol for single-tooth restorations on implants 8 mm or longer with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and central incisors.

Source page: https://510kreport.com/device/K101732
Methodology: https://510kreport.com/methodology