# K040643: Branemark Integration Dental Implant and Accessories

- Pathway: 510(k) (Special)
- Applicant: Branemark Integration AB
- Decided: Apr 7, 2004 after 27 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K083670: Universal, Aesthetica, Natea, Natura (2009), 0 descendants of its own

## Indications for use
The Brinemark Integration AB, implants and accessories 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/K040643
Methodology: https://510kreport.com/methodology