(3 days)
- Direct Restoration of all cavity classes (I-V)
- Base/liner under direct restorations
- Repair of small defects in esthetic indirect restorations
- Repair of resin and acrylic temporary materials
- Pit and fissure sealant
FiltekTM Supreme Flowable Restorative is a low viscosity, visible-light activated, radiopaque, flowable nanocomposite. It is available in a variety of tooth-colored shades. Filtek™ Supreme Flowable Restorative contains Bis GMA, TEGDMA, and Procrylat K resins. The fillers are a combination of an Ytterbium Fluoride filler, a non-agglomerated/non-aggregated surface-modified silica filler, and a surface-modified aggregated zirconia/silica cluster filler. The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume). Filtek Supreme Flowable Restorative is applied to the tooth following the use of a methacrylate-based dental adhesive such as manufactured by 3M, which permanently bonds the restoration to the tooth structure. When irradiated by light, the methacrylate functionalities of the resin and fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive. The product is available in both syringe and capsule delivery systems.
This document describes the 3M™ Filtek™ Supreme Flowable Restorative, a dental material, and its substantial equivalence to predicate devices, focusing on the expansion of its indications for use. As this is a 510(k) submission for a physical medical device (dental restorative material) and not a software or AI-driven device, the detailed questions about acceptance criteria, study design for AI algorithms, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not directly applicable in the context of this document.
However, I can extract and present the information available regarding the device's performance based on the provided text, interpreting the "acceptance criteria" as the regulatory and standard requirements it needed to meet for its expanded indications, and the "study" as the in vitro testing performed.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Standard / Comparator) | Reported Device Performance (3M™ Filtek™ Supreme Flowable Restorative) |
|---|---|---|
| Flexural Strength | Requirements of ISO 4049:2019 and "equivalent or superior as compared to the secondary predicate (Tetric EvoCeram)" | Results met the requirements of ISO 4049:2019. Material strength was equivalent or superior as compared to the secondary predicate. |
| Compressive Strength | Requirements of ISO 4049:2019 and "equivalent or superior as compared to the secondary predicate (Tetric EvoCeram)" | Results met the requirements of ISO 4049:2019. Material strength was equivalent or superior as compared to the secondary predicate. |
| Surface Hardness (Barcol) | Requirements of ISO 4049:2019 and "equivalent or superior as compared to the secondary predicate (Tetric EvoCeram)" | Results met the requirements of ISO 4049:2019. Material strength was equivalent or superior as compared to the secondary predicate. |
| Elastic Modulus/Flexural Modulus | Requirements of ISO 4049:2019 and "equivalent or superior as compared to the secondary predicate (Tetric EvoCeram)" | Results met the requirements of ISO 4049:2019. Material strength was equivalent or superior as compared to the secondary predicate. |
| Radiopacity | Requirements of ISO 4049:2019 and "equivalent or superior as compared to the secondary predicate (Tetric EvoCeram)" | Results met the requirements of ISO 4049:2019. Material strength was equivalent or superior as compared to the secondary predicate. |
| Water Sorption | Requirements of ISO 4049:2019 and "equivalent or superior as compared to the secondary predicate (Tetric EvoCeram)" | Results met the requirements of ISO 4049:2019. Material strength was equivalent or superior as compared to the secondary predicate. |
| Water Solubility | Requirements of ISO 4049:2019 and "equivalent or superior as compared to the secondary predicate (Tetric EvoCeram)" | Results met the requirements of ISO 4049:2019. Material strength was equivalent or superior as compared to the secondary predicate. |
| Fracture Toughness (Chip Resistance) | Requirements of "equivalent or superior as compared to the secondary predicate (Tetric EvoCeram)" | Material strength was equivalent or superior as compared to the secondary predicate. |
| Biocompatibility | Requirements for biocompatibility as per previous clearance of the primary predicate (Filtek™ Supreme Ultra Flowable Restorative) | Confirmed that no additional biocompatibility testing was required as the formulation is identical to the primary predicate and continues to meet biocompatibility requirements. |
| Shelf-Life | Established shelf life for stability | 36 months at ambient temperature (predictive of both syringe and capsule shelf-life stability). |
| Fissure Sealants Performance | Requirements of ISO 6874:2015 Dentistry - Polymer-based pit and fissure sealants | All results met the requirements of ISO 6874:2015. |
| Overall Safety & Efficacy | As safe, as effective, and performs as well as the legally marketed predicate devices for the expanded indications (CFR 872.3690) | The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate devices for its expanded indications, particularly for Classes I, II, and IV restorations, given its equivalence or superiority in material properties to the secondary predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a number of individual samples. However, the text indicates "Testing was undertaken to substantiate the use of the Filtek Supreme Flowable Restorative for Classes I, II, and IV restorations". This implies multiple samples were tested for each physical property to satisfy the requirements of the listed ISO standards. The specific number of specimens for each test (e.g., flexural strength, compressive strength) would be defined by those ISO standards.
- Data Provenance: The testing was "in vitro testing" conducted with the existing flowable restorative material (Filtek™ Supreme Ultra Flowable Restorative, which is identical to the applicant device in formulation) in an updated syringe delivery device. The location of the testing or the origin of the raw materials for testing are not specified beyond the company's location (3M Company ESPE Dental Products, St. Paul, MN, USA). It is a retrospective study in the sense that it relies on the formulation of an existing, cleared device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This question is not applicable. The "ground truth" for this type of device is established through adherence to recognized international standards (ISO) and FDA guidance for material properties. There are no "experts" in the sense of clinicians or radiologists establishing a diagnostic ground truth for individual cases. The standards themselves define the acceptable ranges and methodologies.
4. Adjudication Method for the Test Set:
This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to human expert consensus for diagnostic or grading tasks in clinical studies where individual expert opinions might vary. For material property testing, the results are quantitative measurements interpreted against pre-defined thresholds or compared statistically against predicate devices or standards. There is no human "adjudication" in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This question is not applicable. The device is a dental restorative material, not an AI-driven diagnostic or treatment assistance tool. Therefore, no MRMC study involving human readers with or without AI assistance was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable. The device is a physical dental material, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device is based on:
- International Standards: ISO 4049:2019 (Dentistry - Polymer-based Restorative Materials) and ISO 6874:2015 (Dentistry - Polymer-based pit and fissure sealants).
- FDA Guidance: "Dental Composite Resin Devices – Premarket Notification [510(K)] " issued on October 26, 2005.
- Predicate Device Performance: Comparison to the performance of the primary predicate (3M™ ESPE™ Filtek™ Supreme Ultra Flowable Restorative) and the secondary predicate (Tetric EvoCeram). The "truth" is that the applicant device's performance must meet or exceed the performance of these established devices and regulatory limits for the intended use.
8. The Sample Size for the Training Set:
This question is not applicable. There is no "training set" in the context of a physical dental material and its performance testing. Deep learning or machine learning models require training sets, but this is not an AI or software device.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable, as there is no training set for this type of device.
§ 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.