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Futurabond M+ is intended for use as:

• [A1] Adhesive for direct restorations of all classes of cavities using light-curing . composite /compomer / OrmocerR materials with a methacrylate base.
• [A2] Adhesive for core build-ups made of light-curing composite materials. .
• [A3] Adhesive for indirect restorations with light-curing luting composites. .
• [B] Intraoral repair of composite, compomer or OrmocerR restorations, ceramic veneers and allceramic restorations without an additional primer.
• [C] Treatment of hypersensitive tooth necks. .
• [D] Protective varnish for glass ionomer cement restorations. .
• [E1] Sealing of cavities prior to amalgam restorations. .
• [E2] Sealing of cavities and core preparations prior to the temporary luting of . indirect restorations. In combination with Futurabond M+ DCA (Dual Cure Activator):
• [F1] Adhesive for direct self-curing or dual-curing composite restorations of all . classes of cavities and for core build-ups.
• [F2] Adhesive for indirect restorations using dual-curing or self-curing luting . composites.
• [G] Luting of root posts with dual-curing or self-curing luting composites. .
• [H] Primer for surface preparation of adhesively luted indirect restoration materials . and root posts.

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This document is a 510(k) clearance letter from the FDA for a dental bonding agent called "Futurabond M+". It does not contain any information about acceptance criteria or specific study data showing device performance.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was cleared based on substantial equivalence to existing devices, rather than through a new clinical effectiveness study demonstrating specific performance metrics against pre-defined acceptance criteria.

The document is purely an FDA clearance letter and an "Indications for Use Statement."

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• Futurabond M/Futurabond M Single Dose is suited as adhesive for direct restoration with light-curing filling materials in all cavity classes.
• Futurabond M/Futurabond M Single Dose is also suited for cavity sealing as a pretreatment for indirect restorations
• Futurabond M/Futurabond M Single Dose is also suited for the treatment of exposed root surfaces
• Futurabond M/Futurabond M Single Dose can be used for core build-ups using light-cured or dual-cured filling materials.

Futurabond M/Futurabond M Single Dose is a single-component, light-curing, self-etch-bond reinforced with nano-particles to build a durable bond between tooth substance and light-curing filling materials without marginal leakage.

Futurabond M/Futurabond M Single Dose displays the same adhesive properties of totaletch preparations without separate etching of the tooth substance.

Futurabond M/Futurabond M Single Dose tolerates residual moisture.

Futurabond M/Futurabond M Single Dose is an all-purpose adhesive for use with all lightcuring composites, compomers and Ormocer®s.

Futurabond M/Futurabond M Single Dose is offered in 5 ml plastic bottles (Futurabond M) and in 0.06 ml Single Dose blisters (Futurabond M Single Dose).

This document is a 510(k) summary for the dental adhesive device, "Futurabond M/Futurabond M Single Dose". It does not describe an AI or machine learning device, nor does it provide a study that proves the device meets acceptance criteria in the format requested. Instead, it details the device's characteristics, intended use, and argues for substantial equivalence to predicate devices based on identical composition and performance characteristics.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this document as it pertains to a different type of device and regulatory submission.

However, I can extract the following relevant information:

1. Acceptance Criteria and Reported Device Performance (Implied):

The document implies that the "acceptance criteria" revolve around demonstrating that Futurabond M/Futurabond M Single Dose has "the same adhesive properties" and is "identical in composition and performance characteristics" to the legally marketed predicate devices. This is not a quantitative acceptance criterion with specific thresholds as would be expected for an AI device.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a test set of data. The claims are based on material composition and established performance of predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method for the test set: Not applicable. No adjudication method for a test set is described.

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 applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/ML device. The "ground truth" for this submission is implicitly the established safety and effectiveness of the identified predicate devices, based on their prior regulatory clearance and market history.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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