# K112280: Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar Titanium

- Pathway: 510(k) (Special)
- Applicant: Straumann USA
- Decided: Nov 16, 2011 after 99 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: 12 generations back to K894844 (1990). 77 ancestors in all.
No later device cites it as a predicate yet.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101465: Straumann Cares Bridge; Straumann Cares Dolder Bar, Institut Straumann AG (2010) Summary page 1.

## Indications for use
The Straumann® CARES® Screw-retained Bridge Titanium and Straumann® CARES® Dolder® Bar Titanium are indicated for use as bars and bridges that attach to dental implants (Straumann Regular Neck (RN) 04.8mm and Wide Neck (WN) 06.5mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Straumann® CARES® Screw-retained Bridge Titanium is available in different sizes and spans and can be fitted on 2 to 16 implants. The Straumann® CARES® Dolder® Bar Titanium is available in different sizes and spans and can be fitted on 2 to 10 implants.

Source page: https://510kreport.com/device/K112280
Methodology: https://510kreport.com/methodology