Straumann CARES M-Series CAD/CAM System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203456 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Straumann CARES M-Series CAD/CAM System is a dental device used for the design and manufacturing of dental restorations. It is a computer-aided design and computer-aided manufacturing system intended for use in dental laboratories.
The system is supplied as a reusable software and hardware system for use in dental laboratory settings. It is not sterile and is not intended for single-use. The device has received FDA 510(k) clearance under product code NHA and is substantially equivalent to a legally marketed device.
Frequently asked questions
What is the Straumann CARES M-Series CAD/CAM System used for?
The Straumann CARES M-Series CAD/CAM System is used for the design and manufacturing of dental restorations in dental laboratory settings, enabling computer-aided design and production of prosthetic devices such as crowns and bridges.
Is the Straumann CARES M-Series CAD/CAM System sterile or intended for single-use?
The system is supplied as a reusable software and hardware system and is not sterile; it is not intended for single-use and is designed for repeated use in dental laboratory environments.
How is the Straumann CARES M-Series CAD/CAM System supplied and what does it include?
The device is supplied as a reusable software and hardware system intended for use in dental laboratories, comprising both the CAD/CAM software and associated hardware components necessary for digital design and fabrication of dental restorations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Welcome to Straumann, Straumann Group Login
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203456 | Class II | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (1)
- FDA 510(k) K203456 24 fields · synced Sep 23, 2026