# K962130: Branemark Systems Mkii Selk-Tapping Fixture

- Pathway: 510(k) (Traditional)
- Applicant: Nobelpharma USA, Inc.
- Decided: Jul 22, 1996 after 49 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 K945398 (1995). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945398: Branemark System (R) Mkii Self-Tapping Fixture, Nobelpharma USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K994174: Frialit-2 MH-2 Abutment (2000), 3 descendants of its own
- K122268: Angled Xive MP Abutment, Angled Ankylos (2012), 2 descendants of its own
- K131644: Ankylos Syncone Abutment 5(Degree) (2014), 1 descendant of its own
- K151439: Atlantis Isus (2016), 0 descendants of its own

## Indications for use
The Nobelpharma BRANEMARK SYSTEM - MK II Self-Tapping Fixtures are intended to be used in edentulous and partially edentulous patients to restore chewing functions.

Source page: https://510kreport.com/device/K962130
Methodology: https://510kreport.com/methodology