# K022562: Various Branemark System Implants-Immediate Function Indication

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Oct 11, 2002 after 70 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.
929 later devices descend from it; 19 cite it directly.
0 of 930 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
- K041661: Nobel Biocare Endosseous Implants (2004), 622 descendants of its own
- K030007: Iti Dental Implant System (2003), 570 descendants of its own
- K050705: Tiunite Implants (2005), 532 descendants of its own
- K050258: Groovy Implants (2005), 511 descendants of its own
- K061003: SFB & CFB Implants (2006), 507 descendants of its own

## Indications for use
The Brhemark System implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Brinemark System implants are intended for immediate placement and hnction on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing fitnction. Multiple tooth applications may be splinted with a bar.

Source page: https://510kreport.com/device/K022562
Methodology: https://510kreport.com/methodology