# K201711: CARES Screw - Retained Bars and Bridges (SRBB)

- Pathway: 510(k) (Traditional)
- Applicant: Medentika GmbH
- Decided: Dec 8, 2020 after 168 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: 2 generations back to K132844 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190097: Straumann CARES Screw-Retained Bridges and Bars, Institut Straumann AG (2019) Summary page 5.

## Indications for use
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. CARES® Screw-retained Bridges and Bars are indicated for screw-retained restorations. CARES® Screw - Retained Bars and Bridges are designed to interface with the following dental implant systems (Implant System Compatibility / Series / Implant diameter (mm) / Platform diameter (mm)): Nobel Biocare Replace Select / E-Series / Diameters 3.5, 4.3, 5.0, 6.0 / Platform 3.5, 4.3, 5.0, 6.0 Dentsply Implants - ASTRA TECH OsseoSpeed EV / EV-Series / 3.0, 3.6, 4.2, 4.8, 5.4 / Platform 3.0, 3.6, 4.2, 4.8, 5.4 Nobel Biocare NobelActive / F-Series / Diameter 3.0, 3.5, 4.3, 5.0 / Platform 3.0, 3.5, 3.9 (4.3), 3.9 (5.0) Neodent - Grand Morse / GM Series / Diameters 3.5, 3.75, 4.0, 4.3, 5.0, 6.0 / Platform 3.0 Biomet 3i - Certain / H-Series / Diameter 3.25, 4.0, 5.0 / Platform 3.4, 4.1, 5.0 Biomet 3i – External Hex / I-Series / Diameter 3.25, 3.75, 4.0, 5.0 / Platform 3.4, 4.1, 5.0 Nobel Biocare - Brånemark System / K-Series / Diameter 3.3, 3.75, 4.0, 5.0 / Platform 3.5, 4.1, 4.1, 5.1 Zimmer Dental Tapered Screw-vent / R-Series / Diameter 3.3, 3.7, 4.1, 4.7, 6.0 / Platform 3.5, 4.5, 5.7 Dentsply Implants - ASTRA TECH OsseoSpeed TX / S-Series / Diameter 3.5, 4.0, 4.5, 5.0 / Platform 3.5, 4.0, 4.5, 5.0 Dentsply Implants – XiVE S / T- Series / Diameter 3.4, 3.8, 4.5, 5.5 / Platform 3.4, 3.8, 4.5, 5.5

Source page: https://510kreport.com/device/K201711
Methodology: https://510kreport.com/methodology