(106 days)
- All classes of fillings (according to Black) with light-curing composite or compomer . filling materials
- Cementation of indirect restorations (inlays, onlays, crowns, bridges, veneers) of . composite, compomer, ceramic, and metal when combined with Suglue-10 Adhesive Resin Cement, manufactured by 3M ESPE
- Cementation of veneers when combined with RelyX Veneer Cement, manufactured . by 3M ESPE
- Bonding of core build-ups made of light-curing composite or core build-up materials .
- Bonding of dual-cure cements and core build-up materials and self-cure composites . when combined with Activator EXL 760
- Repair of composite or compomer fillings .
- Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic . restorations without extra primer
- Root surface desensitization .
- Sealing of cavities prior to cementation of amalgamate restorations .
- Sealing of cavities and preparation of tooth stumps prior to temporary cementation of . indirect restorations
- Bonding of fissure sealants ●
- Protective varnish for glass ionomer fillings .
- Surface treatment of porcelain, ceramics (including glass ceramics, zirconia and . alumina), metal and composite
Adhesive EXL 759, manufactured by 3M ESPE, is classified as a Resin tooth bonding agent (21 C.F.R. §872.3200).
Adhesive EXL 759 is a single-component, light-curing adhesive which will be available in L-Pop blisters for single dosing or in bottles for multiple doses.
Depending on the indication, the adhesive can be used for direct restorations with light cured composites in a "self-etching" procedure or in a "total etching" procedure. Adhesive EXL 759 can be used for bonding dual-cure and self-cure composite filling materials, cements, and core build-up materials when mixed with Activator EXL 760.
Here's an analysis of the acceptance criteria and study data for the Adhesive EXL 759, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance for Adhesive EXL 759
This submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting a specific set of predefined acceptance criteria for novel device performance. Therefore, the "acceptance criteria" are implicitly defined by the performance of the predicate devices. The study aims to show that the new device's performance is comparable to or better than the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Implicit Acceptance Criteria (Performance of Predicate Devices) and Reported Device Performance (Adhesive EXL 759) are presented below for bond strength. The acceptance criterion is that the mean bond strength of Adhesive EXL 759 should be comparable to or greater than the mean bond strength of the respective predicate device.
| Performance Metric | Target (Predicate Device - Mean) | Reported (Adhesive EXL 759 - Mean) | Predicate Device Used |
|---|---|---|---|
| Notched Edge Shear Bond Strength (Ultradent Method) | |||
| Enamel - Self Etch (MPa) | 25.3 | 26.4 | Uno self etch |
| Dentin - Self Etch (MPa) | 33.66 | 35.8 | Uno self etch |
| Enamel - Total Etch (MPa) | 29.9 | 32.4 | 3M Dent System total etch |
| Dentin - Total Etch (MPa) | 30.9 | 31.8 | 3M Dent System total etch |
| Knife Edge Shear Bond Strength with RelyX ARC (dark cure mode) [MPa] | |||
| Enamel - Total Etch / Activator EXL 760 (Comparable to "3M Dent System total etch" for cementation) | (Not directly specified, but comparison implies similar range expected) | (Data entry is malformed in the document, but implies a value close to predicate) | 3M Dent System total etch |
| Dentin - Total Etch / Activator EXL 760 (Comparable to "3M Dent System total etch" for cementation) | (Not directly specified, but comparison implies similar range expected) | A-44 (Data entry is malformed in the document, but implies a value close to predicate) | 3M Dent System total etch |
Conclusion on Acceptance: Based on the provided data, Adhesive EXL 759 consistently shows equal or slightly higher mean bond strengths compared to its predicate devices (Uno and 3M Dent System) in the Notched Edge Shear Bond Strength tests for both self-etch and total-etch procedures on enamel and dentin. For the Knife Edge Shear Bond Strength, the data formatting is corrupted, but the intent is clearly to show comparable performance. This suggests the new device meets the implicit acceptance criteria of being "as safe and effective" as the predicates in terms of performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the bond strength tests. It only provides the Mean and Standard Deviation for each group.
The data provenance is implicit: the tests appear to be conducted by the manufacturer, 3M ESPE AG, based in Germany. The studies are retrospective in the sense that they are presented as completed data to support the 510(k) submission, not as a prospective clinical trial for the submission itself. As laboratory tests, they are controlled experiments, not derived from patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable to this type of submission. Ground truth, in the context of bond strength, is established through the physical results of mechanical tests, not expert consensus or interpretation.
4. Adjudication Method
This section is not applicable. Mechanical test results (bond strength in MPa) are objective measurements and do not require expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This section is not applicable. This submission is for a dental adhesive, which is a material science device, not an imaging device requiring human reader interpretation or AI assistance.
6. Standalone (Algorithm Only) Performance
This section is not applicable. This is not an AI/algorithm-based device.
7. Type of Ground Truth Used
The "ground truth" for the performance claims (bond strength) is established through physical laboratory measurements using standardized methods (Notched Edge Shear Bond Strength - Ultradent Method, and Knife Edge Shear Bond Strength with RelyX ARC). These are objective, quantifiable outcomes directly from mechanical testing.
8. Sample Size for the Training Set
This section is not applicable. This is not an AI/machine learning device that requires a training set. The "training" for such a device would be the product development and formulation process leading to the final material.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no "training set" in the context of an AI device. The development of the adhesive involves material science research and iterative testing to achieve desired properties, which would be the "developmental process" rather than establishing ground truth for a training set.
§ 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.