# K022425: Screwline

- Pathway: 510(k) (Special)
- Applicant: Altatec Biotechnologies N.A., Inc.
- Decided: Aug 14, 2002 after 21 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
No predicates in its family tree.
83 later devices descend from it; 5 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061477: Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems (2006), 66 descendants of its own
- K093643: Multi- Unit Abutments for Straumann and Astra Tech Implant Systems (2010), 34 descendants of its own
- K061478: Procera Titanium Abutment for Astratech and Camlog Implant Systems (2006), 33 descendants of its own
- K103252: Camlog Vario SR Abutments (2011), 32 descendants of its own
- K061529: Procera Zirconia Abutment for Camlog Implant System (2006), 26 descendants of its own

## Indications for use
ALTATEC BIOTECHNOLOGIES implants are indicated for single tooth replacement, as immediate abutments, long span to bridgework, as distal abutments on free-standing edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxilla.

Source page: https://510kreport.com/device/K022425
Methodology: https://510kreport.com/methodology