# K021355: Endosseous Implant

- Pathway: 510(k) (Traditional)
- Applicant: Branemark Integration AB
- Decided: Aug 30, 2002 after 123 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: 1 generation back to K925765 (1993). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925765: Branemark System Standard 3.75MM Fixture, Nobelpharma USA, Inc. (1993) Summary page 2.

## Most influential descendants
- K062931: Implus Implant System (2007), 4 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K202832: Implacil Implant System (2021), 0 descendants of its own
- K192839: DSP Implant System (2021), 0 descendants of its own
- K120792: Tixos Implant System (2012), 0 descendants of its own

## Indications for use
The Brinemark Integration AB,FIXTURE ORIGINAL is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

Source page: https://510kreport.com/device/K021355
Methodology: https://510kreport.com/methodology