# K032498: Dental Implant Coping (Prosthetic Accessories to the Iti Dental Implant System)

- Pathway: 510(k) (Special)
- Applicant: Straumann USA
- Decided: Aug 27, 2003 after 14 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K894844 (1990). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022859: Abutment and Prosthetic Accessories to the Iti Dental Implant System, Straumann USA (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K010092: Xltek Evoked Potential Headbox, Model Real Patient EP-8-RP (Proposed), Excel Tech., Ltd. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K070744: Narrow Neck Temporary Coping (2007), 0 descendants of its own

## Indications for use
The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer surface of the coping can be adapted to the individual restoration. The coping is angled and is used only with the IT1 anterior implant.

Source page: https://510kreport.com/device/K032498
Methodology: https://510kreport.com/methodology