# K925762: Branemark System Self-Tapping Fixture

- Pathway: 510(k) (Traditional)
- Applicant: Nobelpharma USA, Inc.
- Decided: Oct 12, 1993 after 333 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
51 later devices descend from it; 2 cite it directly.
0 of 52 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
- K970499: Branemark System Zygomaticus Fixture System (1997), 50 descendants of its own
- K033171: Nsi Hexed and Non-Hexed Implant System and Immediate Loading (2004), 32 descendants of its own
- K052490: Endosseous Dental Implant System (2005), 31 descendants of its own
- K061169: Endosseous Dental Implant (2006), 24 descendants of its own
- K070841: Endosseous Dental Implant System (2007), 21 descendants of its own

## Recalls of this device
- Aug 9, 2019 · Class II · Z-1856-2020: Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment shou

Source page: https://510kreport.com/device/K925762
Methodology: https://510kreport.com/methodology