# K022859: Abutment and Prosthetic Accessories to the Iti Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Straumann USA
- Decided: Sep 19, 2002 after 22 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: 2 generations back to K894844 (1990). 3 ancestors in all.
520 later devices descend from it; 9 cite it directly.
0 of 524 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990342: Synocta Prosthetics, Straumann USA (1999) Summary page 1.

## Most influential descendants
- K041295: RN Synocta Ucla Gold Abutment for the Straumann Dental Implant (2004), 368 descendants of its own
- K051717: RN Synocta Temporary Meso Abutment (2005), 318 descendants of its own
- K070478: P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) (2007), 283 descendants of its own
- K072679: P.004 Abutments (2007), 279 descendants of its own
- K061277: Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping (2007), 265 descendants of its own

## Indications for use
The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge.

Source page: https://510kreport.com/device/K022859
Methodology: https://510kreport.com/methodology