# K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics

- Pathway: 510(k) (Abbreviated)
- Applicant: Lifecore Biomedical, Inc.
- Decided: Sep 9, 2005 after 84 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K960026 (1996). 34 ancestors in all.
40 later devices descend from it; 11 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924589: Restore Self Tapping Dental Implant System, Implant Support Systems, Inc. (1994) Summary page 1.
- K944068: Restore Self Tapping Dental Implant Syst (5, 5.5,6MM), Lifecore Biomedical, Inc. (1995) Summary page 1.
- K951111: Restore Self Tapping Dental Implant System (3.4MM), Lifecore Biomedical, Inc. (1995) Summary page 1.
- K032774: Renova Internal Hex Implant System, Lifecore Biomedical, Inc. (2003) Summary page 1.
- K050506: Primasolo One-Piece Implants & Healing Caps, Lifecore Biomedical, Inc. (2005) Summary page 1.

## Most influential descendants
- K101545: Genesis Implant System (2010), 15 descendants of its own
- K072241: Primaconnex Cad/Cam Abutment System (2007), 7 descendants of its own
- K062876: Primaconnex Ceramic Abutments (2006), 6 descendants of its own
- K160207: ATLANTIS ISUS Implant Suprastructures (2016), 5 descendants of its own
- K163350: Multibase Abutments EV and ATLANTIS Suprastructures (2017), 4 descendants of its own

## Recalls of this device
- May 1, 2018 · Class II · Z-2162-2018: The implants are mislabeled.
- Jun 20, 2017 · Class II · Z-0608-2018: Abutments are unable to accept the final abutment screw
- Mar 9, 2017 · Class II · Z-1818-2017: Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
- Sep 15, 2016 · Class II · Z-0299-2017: Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
- Mar 11, 2013 · Class II · Z-0973-2013: Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled

## Indications for use
Lifecore Biomedical Dental Implant System implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The PrimaConnex Internal Connection Implant is a threaded internal connection implant. The PrimaConnex Internal Connection Implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant into the extraction socket at the time of tooth extraction. The PrimaConnex Internal Connection Implant is intended for immediate provisionalization, non-occlusal load. Immediate Provisionalization defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with or without occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The PrimaConnex Internal Connection Implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.

Source page: https://510kreport.com/device/K051614
Methodology: https://510kreport.com/methodology