# K073049: Screwplus Dental Implants (HA)

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct, LLC
- Decided: Dec 13, 2007 after 45 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 K011245 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011245: Advent Implant System, Swiss Plus Implant System, Sulzer Dental, Inc. (2001)
- K061319: Spectra System, Implant Direct, LLC (2006) Summary page 1.

## Indications for use
The ScrewPlus Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system that is to be used for single-stage or two-stage surgical procedures. The ScrewPlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

Source page: https://510kreport.com/device/K073049
Methodology: https://510kreport.com/methodology