# K894593: Bonefit Hollow Cylinder 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.
536 later devices descend from it; 4 cite it directly.
0 of 537 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
- K983742: Iti Dental Implant System (1999), 510 descendants of its own
- K033984: Straumann Dental Implant System (2004), 376 descendants of its own
- K033922: Modification to Iti Dental Implant System (2004), 346 descendants of its own
- K053088: Slactive Implants (2006), 295 descendants of its own
- K083550: Straumann Dental Implant System (2009), 228 descendants of its own

Source page: https://510kreport.com/device/K894593
Methodology: https://510kreport.com/methodology