# K072151: P.004 RC Cares Titanium and Ceramic Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA
- Decided: Sep 11, 2007 after 39 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894844 (1990). 13 ancestors in all.
264 later devices descend from it; 5 cite it directly.
0 of 278 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.
- K061277: Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping, Straumann USA (2007) Summary page 1.
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 1.

## Most influential descendants
- 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
- K101465: Straumann Cares Bridge; Straumann Cares Dolder Bar (2010), 167 descendants of its own

## Recalls of this device
- Mar 17, 2026 · Class II · Z-1632-2026: A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as 

## Indications for use
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained.

Source page: https://510kreport.com/device/K072151
Methodology: https://510kreport.com/methodology