# K072768: Restore, Stage-1, Renova Primasolo and Primaconnex Dental Implants

- Pathway: 510(k) (Special)
- Applicant: Lifecore Biomedical, Inc.
- Decided: Oct 23, 2007 after 25 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K960026 (1996). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics, Lifecore Biomedical, Inc. (2005)
- K050506: Primasolo One-Piece Implants & Healing Caps, Lifecore Biomedical, Inc. (2005) Summary page 1.
- K032774: Renova Internal Hex Implant System, Lifecore Biomedical, Inc. (2003) Summary page 1.
- K003226: The Lifecore Stage-1 Single Stage RBM Dental Implant System, Lifecore Biomedical, Inc. (2001) Summary page 1.
- K002037: Lifecore Biomedical Dental Implant Systems, Lifecore Biomedical, Inc. (2001) Summary page 1.
- K944068: Restore Self Tapping Dental Implant Syst (5, 5.5,6MM), Lifecore Biomedical, Inc. (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K095111: Restore. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Oct 16, 2017 · Class III · Z-1179-2018: A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.
- Aug 25, 2017 · Class II · Z-0727-2018: The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.

## Indications for use
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/K072768
Methodology: https://510kreport.com/methodology