# K171649: Straumann CARES M-Series CAD/CAM System

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Feb 22, 2018 after 262 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: 15 generations back to K894844 (1990). 189 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111421: Sirona Dental Cad/Cam System, Sirona Dental Systems GmbH (2012) Summary page 4.
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST, Institut Straumann AG (2012) Summary page 4.
- K142890: Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit, Straumann USA, LLC (2015) Summary page 4.
- K150899: Straumann CARES Titanium Alloy (TAN) Abutment, Straumann USA, LLC (2015) Summary page 4.

## Most influential descendants
- K243478: Straumann InLab Validated Workflow (2025), 0 descendants of its own
- K203750: Straumann CARES P-Series CAD/CAM System (2021), 0 descendants of its own
- K203456: Straumann CARES M-Series CAD/CAM System (2021), 0 descendants of its own

## Indications for use
The Straumann CARES M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.

Source page: https://510kreport.com/device/K171649
Methodology: https://510kreport.com/methodology