Straumann CARES Screw-Retained Bridges and Bars
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190097 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 Screw-Retained Bridges and Bars are dental prostheses designed for implant-supported restorations. These devices provide fixed, screw-retained solutions for patients requiring dental reconstruction, offering stability and retention in challenging clinical scenarios. Constructed using materials such as zirconium dioxide and titanium, they are tailored for custom implant prosthetics, ensuring precise fit and functionality.
These devices are supplied as single-use components, intended for use in dental clinics under sterile conditions. They are regulated under FDA 510(k) clearance and MDR compliance, with model-specific variations available for different implant systems. Storage requires adherence to manufacturer guidelines to maintain integrity, and their use is restricted to qualified dental professionals. No additional regulatory status is implied beyond what is explicitly stated.
Frequently asked questions
What materials are used in the Straumann CARES Screw-Retained Bridges and Bars, and why does this matter for patients?
The Straumann CARES Screw-Retained Bridges and Bars are constructed primarily from zirconium dioxide and titanium. Zirconium dioxide is a biocompatible ceramic material known for its aesthetic appeal, as it closely mimics the natural color of teeth, while titanium is a durable metal widely used in dental implants for its strength and osseointegration properties. These materials help ensure a stable, long-lasting restoration that is both functional and visually pleasing for patients.
Are these bridges and bars single-use or reusable, and how should they be handled to maintain sterility?
The Straumann CARES Screw-Retained Bridges and Bars are intended for single-use only under sterile conditions, as specified by the manufacturer. Since they are designed for dental clinics, they must be handled with strict adherence to aseptic techniques to prevent contamination. Proper storage and packaging ensure sterility until use, and any unused components should be discarded according to the manufacturer’s guidelines to maintain patient safety.
What types of implant systems are compatible with these bridges and bars, and how do I know which model to select?
The Straumann CARES Screw-Retained Bridges and Bars are designed with model-specific variations to accommodate different implant systems. While the exact compatibility depends on the patient’s clinical needs and the implant platform used, the manufacturer provides customization options to ensure a precise fit. Clinicians should consult the product documentation or contact Straumann’s technical support to confirm which model aligns with their patient’s specific implant system and restoration requirements.
How should these devices be stored to preserve their integrity, and is there a shelf life or expiration consideration?
Storage of the Straumann CARES Screw-Retained Bridges and Bars must follow the manufacturer’s guidelines to maintain their structural integrity and sterility. While the exact storage conditions (e.g., temperature, humidity) are not detailed here, they are typically packaged to protect against damage and contamination. Clinicians should verify the packaging instructions for any expiration dates or storage limitations, as improper handling could compromise performance or safety before use.
What regulatory pathways have been followed for these devices, and how does this affect their use in clinical practice?
The Straumann CARES Screw-Retained Bridges and Bars have undergone FDA 510(k) clearance and MDR compliance, confirming their safety and effectiveness for their intended use. This regulatory approval ensures they meet stringent standards for dental prosthetics in the U.S. and European markets, respectively. Clinicians can rely on these pathways to confirm the devices are suitable for implant-supported restorations, though only qualified dental professionals should handle and install them as per manufacturer instructions.
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: Straumann® CARES® Screw-retained Bridge, Straumann® CARES® Screw-retained Bars & Bridges, PDF Straumann® CARES® Screw Retained Bars for Straumann® Pro A, Straumann® CARES® Prosthetics - Institut Straumann - PDF Catalogs ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K190097 | Class II | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (2)
- FDA 510(k) K190097 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026