# K081005: P.004 NC Cares Titanium and Ceramic Abutments

- Pathway: 510(k) (Special)
- Applicant: Institut Straumann AG
- Decided: May 2, 2008 after 24 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: 8 generations back to K894844 (1990). 14 ancestors in all.
263 later devices descend from it; 8 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)
- K072151: P.004 RC Cares Titanium and Ceramic Abutments, Straumann USA (2007) Summary page 1.

## Most influential descendants
- 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
- K113283: NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC Basal Screw  Cementable Abutments (2011), 166 descendants of its own

## Recalls of this device
- Jul 11, 2012 · Class II · Z-2161-2012: Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2

## Indications for use
Abutments are placed in the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures. The P.004 NC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations. The P.004 NC 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/K081005
Methodology: https://510kreport.com/methodology