# K951111: Restore Self Tapping Dental Implant System (3.4MM)

- Pathway: 510(k) (Traditional)
- Applicant: Lifecore Biomedical, Inc.
- Decided: Mar 31, 1995 after 21 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.
80 later devices descend from it; 3 cite it directly.
0 of 81 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
- 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
- K020617: Nsi Hexed and Non-Hexed Implant System (2002), 36 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

Source page: https://510kreport.com/device/K951111
Methodology: https://510kreport.com/methodology