# K945398: Branemark System (R) Mkii Self-Tapping Fixture

- Pathway: 510(k) (Traditional)
- Applicant: Nobelpharma USA, Inc.
- Decided: Apr 13, 1995 after 161 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.
14 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021322: Endossous Implants (2002), 6 descendants of its own
- K103194: Intra-Lock Dental Implants with Blossom (2011), 5 descendants of its own
- K962130: Branemark Systems Mkii Selk-Tapping Fixture (1996), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K945398
Methodology: https://510kreport.com/methodology