(7 days)
BC Plus™ is a light curing single component bonding agent use in restorative adhesive dentistry specifically developed for bonding resin-based filling materials (e.g. composites, compomers) to hard dental tissues. Other indications include bonding of amalgam and laboratory-produced restorations. BC Plus™ permits priming and bonding to be carried out in single step.
BC Plus™ is a single component bonding agent designed to bond composite to dentin, enamel, cast metals, treated porcelain and set amalgam. BC Plus™ is an ethanol based formulation of light-activated, adhesive resin.
The provided 510(k) summary for the Vericom Co. Ltd. BC Plus™ device does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Kaazaas) rather than presenting detailed performance data against specific acceptance criteria. The document states that the device "has been subjected to extensive safety, performance, and product validations prior to release," but it does not elaborate on these validations, their results, or the acceptance criteria used.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. All other requested details related to a specific performance study (sample size, data provenance, expert-established ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and training set ground truth establishment) are also absent from this submission.
Summary of missing information based on the prompt's request:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on substantial equivalence based on similar material, design, and use concept to the predicate device.
- Sample size used for the test set and the data provenance: Not present. No specific test set or study details are provided.
- 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 (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable, as this is a resin tooth bonding agent, not an AI/algorithm-based device.
- The type of ground truth used: Not present.
- The sample size for the training set: Not applicable (not an AI/algorithm device), and no training data for general device performance is mentioned.
- How the ground truth for the training set was established: Not applicable.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.