# K924589: Restore Self Tapping Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Support Systems, Inc.
- Decided: Jun 22, 1994 after 650 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.
53 later devices descend from it; 5 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K032774: Renova Internal Hex Implant System (2003), 49 descendants of its own
- K050506: Primasolo One-Piece Implants & Healing Caps (2005), 43 descendants of its own
- K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics (2005), 40 descendants of its own
- K101545: Genesis Implant System (2010), 15 descendants of its own
- K072241: Primaconnex Cad/Cam Abutment System (2007), 7 descendants of its own

Source page: https://510kreport.com/device/K924589
Methodology: https://510kreport.com/methodology