# K190097: Straumann CARES Screw-Retained Bridges and Bars

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Jun 26, 2019 after 155 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: 1 generation back to K132844 (2014). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132844: Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level Screw Retained Bridges, Straumann USA, LLC (2014) Summary page 4.

## Most influential descendants
- K201711: CARES Screw - Retained Bars and Bridges (SRBB) (2020), 0 descendants of its own

## Indications for use
Straumann® CARES® Screw-retained Bridges and Bars are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann® CARES® Screw-retained Bridges and Bars are indicated for screw-retained restorations. Straumann® CARES® Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), and BLX implants of the Straumann Dental Implant System (SDIS).

Source page: https://510kreport.com/device/K190097
Methodology: https://510kreport.com/methodology