(115 days)
Futurabond Universal is intended for use as:
- Adhesive for direct restorations of all classes of cavities using light-curing composite/compomer/Ormocer materials with a methacrylate base
- Adhesive for core build-ups made of light-curing composite materials
- Adhesive for indirect restorations with light-curing luting composites .
- Intracral repair of composite, compomer or Ormocer restorations, ceramic veneers and all ceramic restorations without an additional primer
- Treatment of hypersensitive tooth necks
- Protective vamish for glass ionomer cement restorations
- Sealing of cavities prior to amalgam restorations
- Sealing of cavities and core preparations prior to the temporary luting of indirect restorations
- Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups
- Adhesive for indirect restorations using dual-curing or self-curing luting composites
- Luting of root posts with dual-curing or self-curing luting composites
Not Found
This FDA 510(k) clearance letter for the Futurabond U device does not contain any information about acceptance criteria or a study that proves the device meets such criteria.
The document is a clearance letter, confirming that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices for the specified indications for use. It outlines administrative details like regulation numbers, product codes, and general controls provisions of the Act.
Therefore, I cannot provide the requested information as it is not present in the provided text.
To illustrate, if the document had contained information about a study, it might have looked something like this (this is a hypothetical example of what one would look for):
Hypothetical Section from a different document (NOT from the provided text):
"Clinical Study Results for Futurabond U
A prospective, randomized, controlled clinical trial was conducted to evaluate the bond strength and clinical longevity of Futurabond U compared to a predicate device.
Acceptance Criteria:
- Shear Bond Strength (SBS) to Enamel: Mean SBS ≥ 15 MPa
- Shear Bond Strength (SBS) to Dentin: Mean SBS ≥ 10 MPa
- Retention Rate at 12 Months: ≥ 95%
- Marginal Adaptation: No significant deterioration (score 0 or 1 on a 0-3 scale) in >90% of restorations at 12 months.
Reported Device Performance:
| Acceptance Criteria | Futurabond U Performance | Meets Criteria? |
|---|---|---|
| Shear Bond Strength (SBS) to Enamel | 18.2 ± 2.1 MPa | Yes |
| Shear Bond Strength (SBS) to Dentin | 12.5 ± 1.8 MPa | Yes |
| Retention Rate at 12 Months | 96.7% | Yes |
| Marginal Adaptation (score 0 or 1) at 12 Mos | 93.5% | Yes |
Study Details:
- Test Set Sample Size: 250 patients, with a total of 500 restorations (250 Futurabond U, 250 predicate).
- Data Provenance: Prospective, multi-center study conducted in the USA, Germany, and Japan.
- Experts for Ground Truth: 5 board-certified restorative dentists, each with an average of 15 years of clinical experience.
- Adjudication Method: 3+1 (three dentists independently evaluated each restoration; in case of disagreement, a fourth senior dentist adjudicated).
- MRMC Comparative Effectiveness Study: No, this was a direct comparison of device performance, not a reader study.
- Standalone Performance: Yes, the above metrics represent the performance of the algorithm (device) itself.
- Type of Ground Truth: Clinical outcome data (retention, marginal adaptation) and ex vivo laboratory measurements (bond strength).
- Training Set Sample Size: Not applicable for a dental bonding agent; performance is based on material properties and clinical application.
- Ground Truth for Training Set: Not applicable. Material properties are established through chemical and physical testing during product development.
End Hypothetical Section
The provided document {0}, {1}, {2} is purely an FDA clearance letter and does not include any of the detailed study information or acceptance criteria for performance metrics.
§ 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.