# K894844: Bonefit Implant System Accessories & Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Straumann Institute, Ltd.
- Decided: Feb 2, 1990 after 186 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.
764 later devices descend from it; 8 cite it directly.
0 of 765 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
- K990342: Synocta Prosthetics (1999), 696 descendants of its own
- K013798: Prosthetic Accessories to the Iti Dental Implant System (2001), 575 descendants of its own
- K012757: Iti Dental Implant System (2001), 535 descendants of its own
- K022859: Abutment and Prosthetic Accessories to the Iti Dental Implant System (2002), 520 descendants of its own
- K020096: Esthetic Ease Abutments for the Iti Dental Implant System (2002), 516 descendants of its own

Source page: https://510kreport.com/device/K894844
Methodology: https://510kreport.com/methodology