# K050506: Primasolo One-Piece Implants & Healing Caps

- Pathway: 510(k) (Abbreviated)
- Applicant: Lifecore Biomedical, Inc.
- Decided: Apr 15, 2005 after 46 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
Longest line of descent: 8 generations back to K960026 (1996). 33 ancestors in all.
43 later devices descend from it; 3 cite it directly.
0 of 77 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.
- K992512: Altiva Corporation NTR 3.3 MM Self-Tapping Screw Implants, Altiva Corporation Corporation NTR-3.3 MM Self-Tapping HA Coa, Imcor (1999) Summary page 1.
- K023952: Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite, Nobel Biocare Uas, Inc. (2003) Summary page 1.
- K031345: Nobel Direct, Models 30937, 30938, Nobel Biocare Uas, Inc. (2003) Summary page 1.
- K032351: The Maestro System 3.0MM Diameter Implant, BioHorizons Implant Systems, Inc. (2003) Summary page 1.
- K032774: Renova Internal Hex Implant System, Lifecore Biomedical, Inc. (2003) Summary page 2.

## Most influential descendants
- 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
- K062876: Primaconnex Ceramic Abutments (2006), 6 descendants of its own
- K160207: ATLANTIS ISUS Implant Suprastructures (2016), 5 descendants of its own

## 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. Specific Intended Uses: The PrimaSolo One-Piece (3.5 - 5.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for single-stage surgical procedure and cemented restorations. The PrimaSolo One-Piece Implant is intended for immediate placement and can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone. The PrimaSolo One-Piece (3.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for single-stage surgical procedure and is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

Source page: https://510kreport.com/device/K050506
Methodology: https://510kreport.com/methodology