# K091878: Osseolink Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Global Implant Solutions, LLC
- Decided: Oct 6, 2009 after 105 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: 6 generations back to K894595 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013227: Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. (2001)
- K050258: Groovy Implants, Nobel Biocare AB (2005) Summary page 3.

## Indications for use
OsseoLink dental implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The OsseoLink Dental System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. The placement of individual 0 3.5 mm diameter implants in the molar region in not recommended. OsseoLink prosthetic abutments are intended for use with OsseoLink dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. OsseoLink cover screws are used when submerged healing is desired in two stage implant surgery procedures. OsseoLink healing abutments are used at the time of implant placement when non-submerged (i.e., single-stage) surgical placement is indicated or following the uncovering of an implant when the two-stage protocol is followed.

Source page: https://510kreport.com/device/K091878
Methodology: https://510kreport.com/methodology