# K082800: Star/Vent Internal Hex Screw Implant

- Pathway: 510(k) (Traditional)
- Applicant: Park Dental Research Corp.
- Decided: Aug 26, 2010 after 701 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: 10 generations back to K960026 (1996). 76 ancestors in all.
No later device cites it as a predicate yet.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063364: Alpha Bio Dental Implant System, Alpha-Bio Tec, Ltd. (2007) Summary page 1.
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants, Implant Innovations, Inc. (2002) Summary page 1.
- K022113: 3I Dental Implant Accessories, Implant Innovations, Inc. (2002) Summary page 1.
- K003191: Mis Implant System Decive, Mis Implants Technologies, Ltd. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K040007: Interferential Stimulator, Model BMLS02-6, Biomedical Life Systems, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The StarNent Internal Hex Screw Implant is intended for placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in edentulous or partially edentulous patients and to restore the patient's chewing function. It is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading,

Source page: https://510kreport.com/device/K082800
Methodology: https://510kreport.com/methodology