# K061277: Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Apr 12, 2007 after 339 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: 6 generations back to K894844 (1990). 10 ancestors in all.
265 later devices descend from it; 4 cite it directly.
0 of 276 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052272: Straumann Computer Aided Restoration Service, Straumann USA (2006) Summary page 1.
- K033243: Iti Synocta Meso Abutments, Straumann USA (2003) Summary page 1.
- K012473: Vident Hextop, Synocta in-Ceram Blank/Coping Manufactured by Vident, Vident (2002) Summary page 1.
- K022859: Abutment and Prosthetic Accessories to the Iti Dental Implant System, Straumann USA (2002) Summary page 1.
- K990342: Synocta Prosthetics, Straumann USA (1999) Summary page 1.

## Most influential descendants
- K072151: P.004 RC Cares Titanium and Ceramic Abutments (2007), 264 descendants of its own
- K081005: P.004 NC Cares Titanium and Ceramic Abutments (2008), 263 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K082545: Straumann NN Cares Titanium and Ceramic Abutments (2008), 171 descendants of its own
- K093113: Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment (2009), 169 descendants of its own

## Indications for use
Copings are intended to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Ceramic Coping is indicated for cemented restorations. The coping can be used in single tooth replacements and multiple tooth restorations.

Source page: https://510kreport.com/device/K061277
Methodology: https://510kreport.com/methodology