# K992538: Amorphous Diamond Coated Screw

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Nov 23, 1999 after 116 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 K964739 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964739: Steri-Oss Tiodized Screw, Steri-Oss, Inc. (1997) Summary page 1.

## Most influential descendants
- K161177: Axiom PX (2017), 0 descendants of its own

## Indications for use
The Amorphous Diamond Coated Screw is used to retain prosthetic components to dental implants or to other prosthetic components. The amorphous diamond coating will add a greater pre-load to the screw, which in turn help prevent the screw and prosthetic components from loosening.

Source page: https://510kreport.com/device/K992538
Methodology: https://510kreport.com/methodology