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FL-BOND II is a dental bonding agent for composite resin to bond light-cured dental composite resin to tooth, metal, porcelain and resin for crown restorations. It consists of 3 materials, ETCHANT, PRIMER, and BONDING AGENT. Specific uses are as follows:

1. Filling restoration of tooth
2. Pretreatment of tooth, to which crown restoration is bonded using dental adhesive resin cement
3. Repair of crown restoration

FL-BOND II is a dental bonding agent for composite resin to bond light-cured dental composite resin to tooth, metal, porcelain and resin for crown restorations. It consists of 3 materials, ETCHANT, PRIMER, and BONDING AGENT.

This document is a 510(k) clearance letter for a dental bonding agent (FL Bond II) and primarily focuses on the regulatory approval based on substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or performance study report would.

Therefore, most of the requested information cannot be extracted from the provided text. The document is a regulatory approval, not a performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

   • Not provided. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning its performance is considered comparable to existing, approved devices. However, explicit acceptance criteria and corresponding reported performance metrics are not detailed in this regulatory letter.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not provided. This information would typically be found in a study report, not a 510(k) clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not provided. This letter does not describe a study involving expert readers or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not provided. This device is a dental bonding agent, which is a material, not an AI or imaging device that would typically involve MRMC studies for human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not provided. This is not an algorithm, but a physical dental product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not provided.

8. The sample size for the training set

   • Not provided.

9. How the ground truth for the training set was established

   • Not provided.

In summary: The provided FDA 510(k) clearance letter confirms that the FL Bond II dental bonding agent has been deemed substantially equivalent to a predicate device. It defines the "Indications For Use" (listed as filling restoration, pretreatment for crown bonding, and repair of crown restoration). However, it does not include the detailed performance study results, acceptance criteria, or ground truth establishment methods typically found in a clinical trial report or a performance evaluation study.

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