# K063779: Osseospeed 4.0S-6MM, Model 24619

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Apr 27, 2007 after 127 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.
75 later devices descend from it; 4 cite it directly.
0 of 76 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
- K103089: Seven Implants; Biocom Implants; Lance Implants (2011), 49 descendants of its own
- K132125: A.B. Dental Devices Dental Implants System (2014), 25 descendants of its own
- K140440: Noris Medical Dental Implants System (2014), 14 descendants of its own
- K113779: Conelog Implant System (2012), 14 descendants of its own
- K180282: MIS Internal Hex Dental Implant System (2018), 11 descendants of its own

## Indications for use
The OsseoSpeed TM system is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained. 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 after implantation where immediate implant stability may be obtained. The fluoride-modified surface, though having a fluoride ion level far below tat needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. OsseoSpeed implants are 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 4.0S - 6 mm implant.

Source page: https://510kreport.com/device/K063779
Methodology: https://510kreport.com/methodology