(49 days)
BEAUTIFIL II is a visible light curing dental filling composite resin having radiopacity, which is used for various restorations. It is suitable for filling and repairing for anterior and posterior, such as class I through V restorations, wedge shaped defects and root caries. It can be also applied to core build-up and repair of fractured laminate veneer, porcelain, composite resin and C&B materials.
BEAUTIFIL II is a visible light curing dental filling composite resin having radiopacity.
The provided document is a 510(k) clearance letter from the FDA for a dental filling composite resin named "Beautifil II" (K071742). It indicates that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
The letter focuses on regulatory approval based on demonstrating substantial equivalence, not on providing detailed performance data from a specific study against pre-defined acceptance criteria. The indications for use are mentioned, but no performance metrics are listed.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample sizes used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present.
- If a standalone study was done: Not explicitly detailed with performance metrics. The letter implies comparison to a predicate, not standalone performance against acceptance criteria.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
The document's purpose is to grant marketing clearance, not to publish detailed study results. Such study details would typically be found in the 510(k) submission itself, which is not publicly available in this format, or in associated clinical publications.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.