# K080156: Osseospeed TM  Profile System

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech AB
- Decided: Sep 17, 2008 after 238 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.
67 later devices descend from it; 6 cite it directly.
0 of 68 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
- K093643: Multi- Unit Abutments for Straumann and Astra Tech Implant Systems (2010), 34 descendants of its own
- K132125: A.B. Dental Devices Dental Implants System (2014), 25 descendants of its own
- K103759: Atlantis Abutment in Zirconia for Osseospeed TX Profile Implant (2011), 19 descendants of its own
- K130999: Osseospeed Profile EV (2013), 18 descendants of its own
- K140440: Noris Medical Dental Implants System (2014), 14 descendants of its own

## Indications for use
OsseoSpeedTM Profile 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 fluoride-modified 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. OsseoSpeed Profile 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.

Source page: https://510kreport.com/device/K080156
Methodology: https://510kreport.com/methodology