# K944069: Restore TPS Lhex Cylinder Endosseous Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Lifecore Biomedical, Inc.
- Decided: Feb 28, 1995 after 194 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.
506 later devices descend from it; 1 cites it directly.
0 of 507 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
- K981858: Atlantis Abutment and Atlantis Abutment Screw (1999), 505 descendants of its own
- K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar (2004), 476 descendants of its own
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 (2004), 441 descendants of its own
- K062069: Atlantis Abutment for 3I Micromini Implant (2007), 361 descendants of its own
- K070833: Atlantis Abutment for Astra Implant (2007), 357 descendants of its own

Source page: https://510kreport.com/device/K944069
Methodology: https://510kreport.com/methodology