# K091239: Astra Tech Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech AB
- Decided: Sep 22, 2009 after 148 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
No predicates in its family tree.
228 later devices descend from it; 6 cite it directly.
0 of 229 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K101732: Astra Tech Implant System (2011), 214 descendants of its own
- 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

## Indications for use
Astra Tech Implant System is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The OsseoSpeed Narrow product line shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. The fluoride-modified implant surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Astra Tech Implant System is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type. IV bone, immediate loading of single tooth restorations may not be appropriate in such situations. Immediate loading of single tooth restorations is not recommended for the OsseoSpeed Tm 4.OS - 6 mm implant.

Source page: https://510kreport.com/device/K091239
Methodology: https://510kreport.com/methodology