(70 days)
Silver based alloy dental restorative used in all classes of restorations.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental alloy. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Specifically:
- Acceptance criteria and reported device performance: Not present. This document is a regulatory clearance, not a performance report.
- Sample size, data provenance: Not present.
- Number of experts and qualifications: Not present.
- Adjudication method: Not present.
- MRMC comparative effectiveness study: Not present.
- Standalone performance study: Not present.
- Type of ground truth: Not present.
- Sample size for training set: Not present.
- How ground truth for training set was established: Not present.
The document discusses the regulatory determination of substantial equivalence for the "Benco Admix" dental restorative, indicating it's an amalgam alloy used in all classes of restorations. It refers to general controls and existing regulations but does not detail any performance studies or their associated acceptance criteria.
§ 872.3070 Dental amalgam, mercury, and amalgam alloy.
(a)
Identification. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”See § 872.1(e) for the availability of this guidance document.