# K894595: Bonefit R Screw Implants

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Feb 13, 1990 after 204 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.
1,051 later devices descend from it; 7 cite it directly.
0 of 1,052 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
- K984104: Iti Dental Implant System (1999), 1,043 descendants of its own
- K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement) (2000), 942 descendants of its own
- K992937: Dental Implant (2000), 735 descendants of its own
- K023113: Replace Tiunite Endosseous Implant (2002), 689 descendants of its own
- K041661: Nobel Biocare Endosseous Implants (2004), 622 descendants of its own

Source page: https://510kreport.com/device/K894595
Methodology: https://510kreport.com/methodology