(13 days)
- Direct anterior and posterior restorations (including occlusal surfaces)
- Base/liner under direct restorations
- Core build-ups
- Splinting
- Indirect restorations including inlays, onlays and veneers
- Restorations of deciduous teeth
- Extended fissure sealing in molars and premolars
- Repair of defects in porcelain restorations, enamel, and temporaries
3MTM FiltekTM One Bulk Fill Restorative, is a visible-light activated, restorative composite optimized to create fast and easy restorations. This material provides excellent strength and low wear for durability and improved esthetics. The material can be placed and cured up to 5mm deep, enabled by a stress relieving resin system and optimized optical properties. Filtek™ One Bulk Fill Restorative serves to enhance the 3M ESPE lineup of restorative materials by improving the esthetic properties of a bulk fill material to allow for broader use in both posterior and anterior restorations. Filtek™ One Bulk Fill Restorative is offered in a range of tooth-colored shades. All shades are radiopaque.
This document is a 510(k) Summary for a dental restorative device, 3M™ Filtek™ One Bulk Fill Restorative. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting a standalone study with acceptance criteria and device performance in the way typically seen for AI/software devices.
Therefore, many of the requested elements (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance with specific metrics like sensitivity/specificity, and provenance of data) are not applicable or not provided in this type of submission.
However, I can extract the information that is present regarding technological characteristics, which serves a similar purpose to acceptance criteria and performance for this specific type of device (a material whose performance is evaluated against physical and chemical properties).
Here's an attempt to structure the available information according to your request, with the understanding that it's a materials science context, not an AI/software context:
1. Table of Acceptance Criteria and Reported Device Performance
For a dental restorative material, "acceptance criteria" are typically defined by recognized standards (like ISO) for physical and chemical properties, and "reported device performance" are the results of tests against these standards. The submission asserts substantial equivalence by showing similar or improved
performance compared to the predicate device, also in compliance with these standards.
| Acceptance Criteria (Defined by ISO Standards/Predicate Performance) | Reported Device Performance (Filtek™ One Bulk Fill Restorative) |
|---|---|
| Physical/Chemical Properties: | Test Results Included (Asserted to meet standards): |
| Compressive Strength (ISO 4049:2009) | Included in submission, assumed to be equivalent or superior to predicate. |
| Diametral Tensile Strength (ISO 4049:2009) | Included in submission, assumed to be equivalent or superior to predicate. |
| Flexural Strength (ISO 4049:2009) | Included in submission, assumed to be equivalent or superior to predicate. |
| Flexural Modulus (ISO 4049:2009) | Included in submission, assumed to be equivalent or superior to predicate. |
| Surface Hardness (ISO 4049:2009) | Included in submission, assumed to be equivalent or superior to predicate. |
| Radiopacity (ISO 4049:2009) | Included in submission, assumed to be equivalent or superior to predicate. |
| Water Sorption (ISO 4049:2009) | Included in submission, assumed to be equivalent or superior to predicate. |
| Water Solubility (ISO 4049:2009) | Included in submission, assumed to be equivalent or superior to predicate. |
| Volumetric Shrinkage (ISO 4049:2009) | Included in submission, assumed to be equivalent or superior to predicate. |
| Wear (ISO 4049:2009) | Included in submission, assumed to be equivalent or superior to predicate. |
| Depth of Cure (ISO 4049:2009 requirement for 3mm) | Passes 3mm depth of cure requirement, and supports up to 5mm with specific protocols. |
| Cusp Deflection (Not explicitly standard, but relevant to bulk fill) | Included in submission, assumed to be equivalent or superior to predicate. |
| Polish Retention (Not explicitly standard, but relevant to esthetics) | Included in submission, assumed to be equivalent or superior to predicate. |
| Biocompatibility: | Assessment Conclusion: |
| ISO 10993 Series (e.g., Cytotoxicity, Sensitization, Irritation) | Assessed as safe for intended use by a Diplomate of the American Board of Toxicology. |
| Functional/Technological Equivalence: | Comparison to Predicate (Filtek™ Bulk Fill Posterior Restorative): |
| Photoinitiator system | X (Present and equivalent) |
| Methacrylate-based resin matrix | X (Present and equivalent) |
| Compatible with methacrylate-based dental adhesives | X (Present and equivalent) |
| Inorganic fillers | X (Present and equivalent) |
| Oxide fillers silane treated for bonding | X (Present and equivalent) |
| Curing depth: up to 3 mm (with reduced light-cure time) | X (Added for Filtek™ One, passes ISO 4049 3mm requirement) |
| Curing depth: up to 4 mm | X (Present and equivalent) |
| Multi-surface light-cure (5 mm for Class II restorations) | X (Present and equivalent) |
| Multi-surface light-cure (5 mm for Core Build-Up) | X (Added for Filtek™ One, expected to perform adequately) |
| Dispensing system (single-use capsule, reusable syringe) | X (Present and equivalent) |
| Recommended for load-bearing occlusal surfaces | X (Present and equivalent) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of typical AI algorithm evaluation. Performance is based on various in-vitro physical and chemical tests, where sample sizes would be dictated by the specific ISO standards for each test (e.g., multiple specimens for strength tests, etc.). These details are not provided in the summary.
- Data Provenance: Not specified for testing. These are laboratory-based, in-vitro tests conducted by the manufacturer, 3M ESPE Dental Products.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: One expert is explicitly mentioned for biocompatibility assessment: "A Diplomate of the American Board of Toxicology."
- Qualifications of Experts: For biocompatibility, "Diplomate of the American Board of Toxicology." For the physical property tests, "ground truth" is established by adherence to recognized international standards (e.g., ISO 4049, ISO 10993 series), and testing is performed in laboratories, typically by qualified technicians or scientists, but their specific number or detailed qualifications are not provided in this summary.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. The evaluation methods for material properties are standardized laboratory tests, not subjective expert adjudication typical for complex diagnostic tasks. The decision for substantial equivalence is made by the FDA based on the submitted data and comparison to the predicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This device is a dental restorative material, not an AI or software device that assists human readers in interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only) Performance
- Not applicable. This submission is for a physical material, not an algorithm, so the concept of "standalone performance" of an algorithm is not relevant. The performance of the material is evaluated directly through physical and chemical tests.
7. The Type of Ground Truth Used
- For Biocompatibility: Expert assessment (Diplomate of the American Board of Toxicology) based on standard risk assessment techniques and international guidelines.
- For Physical/Chemical Properties: Defined by adherence to established international standards (e.g., ISO 4049:2009 for various properties like strength, depth of cure, etc.; ISO 14971:2007 for Risk Management; ISO 10993 series for Biocompatibility). These standards specify the methods and criteria for evaluating the material's properties.
8. The Sample Size for the Training Set
- Not applicable. This is a physical material, not a machine learning model. There is no concept of a "training set" for this type of device submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
§ 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.