Search Results

Copings are intended to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Ceramic Coping is indicated for cemented restorations. The coping can be used in single tooth replacements and multiple tooth restorations.

The Straumann Dental Implant System is an integrated system of endosseous dental implants designed to support prosthetic restorations (crowns, bridges, overdentures). The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The subject device, the Straumann C.A.R.E.S. Ceramic Coping, is designed to be custom modified for a particular patient, the coping is fixed to a synOcta® 1.5 abutment which is then fixed to the implant. The ceramic coping provides support for prosthetic reconstructions, such as crowns or bridges.

The Straumann C.A.R.E.S. Ceramic Coping is intended for cemented restorations and can be customized to meet high anatomical and esthetic demands. The esthetic properties of the Straumann C.A.R.E.S. Ceramic Coping are designed to create a natural appearance of the soft tissue margin as well as excellent results for crown restoration.

The provided text describes a 510(k) submission (K061277) for the Straumann C.A.R.E.S. Ceramic Coping. This is a premarket notification for a medical device aiming to demonstrate substantial equivalence to previously cleared predicate devices, rather than a study proving the device meets specific acceptance criteria through performance data.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training and test sets.

The relevant sections of the document focus on:

• Device Identification: Trade Name, Common Name, Classification.
• Predicate Devices: Listing previously cleared devices to which equivalence is claimed.
• Device Description: What the Straumann C.A.R.E.S. Ceramic Coping is and its function (custom-modified coping for cement-retained restorations, providing support for crowns/bridges).
• Intended Use: Similar to the description, detailing its use in aesthetic regions for cemented restorations.
• Basis for Substantial Equivalence: Arguing that the subject device is similar in design, indications for use, technological characteristics (material, principles of operation, basic design), and manufacturing process (software and milling) to the predicate devices.

Conclusion:

The 510(k) submission for K061277 does not detail specific acceptance criteria, performance data from a clinical or technical study, sample sizes, expert involvement, or ground truth methodologies as it relies on demonstrating substantial equivalence to predicate devices rather than providing new performance outcome data.

Ask a specific question about this device