# K080633: Screwindirect Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct, LLC
- Decided: Jul 15, 2008 after 132 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: 1 generation back to K061319 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061319: Spectra System, Implant Direct, LLC (2006) Summary page 1.

## Indications for use
ScrewIndirect Narrow Dental Implants are implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for immediate loading for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

Source page: https://510kreport.com/device/K080633
Methodology: https://510kreport.com/methodology