# K070184: Dental Implant, Dental Abutment, Abutment Screw, Cover Screw, Healing Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Ospol AB
- Decided: Mar 24, 2008 after 430 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: 6 generations back to K894595 (1990). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050705: Tiunite Implants, Nobel Biocare AB (2005) Summary page 1.
- K053384: Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System, Astra Tech, Inc. (2006) Summary page 1.

## Most influential descendants
- K142082: Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour Abutement (2014), 0 descendants of its own

## Indications for use
The Ospol AB, OspolDentallmplantSystem is intended for surgical placement into the bone of upper /lowerjaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

Source page: https://510kreport.com/device/K070184
Methodology: https://510kreport.com/methodology