(9 days)
Direct Indications:
· Bonding for all methacrylate-based light-, dual-, and self-cure composite or compomer filling materials
·Root surface desensitization
· Bonding of methacrylate-based fissure sealants
· Protective varnish for glass ionomer fillings
·Repair of composite and compomer fillings
· Sealing of cavities prior to placement of amalgam restorations
Indirect Indications:
· Cementation of indirect restoration with Suglue 3 and other resin cements (follow applicable Instructions for Use)
· Bonding for all methacrylate-based light-, self-, and dual-cure core build-up materials and cements
· Cementation of veneers when combined with RelyX Veneer Cement
· Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
•Sealing of cavities and preparation of tooth stumps prior to temporary cementation of indirect restorations
ADH19 is a one-component dental adhesive that is based on the chemistry of Scotchbond Universal (by 3M Deutschland GmbH, K110302, cleared as ADHESIVE EXL-759). It can be used in a self-etch mode, selective enamel etch mode or in a total-etch mode for both direct and indirect dental restorative procedures. It is intended to bond methacrylate-based restorative, cement and sealant materials to dentin, enamel, glass ionomer and various indirect restorative substrates (metals, glass ceramics, alumina and zirconia). The primary use will be with lightcured materials, however it will have the capability to also bond self- or dual-cure composite and cement materials. In contrast to Scotchbond Universal, no separate Dual Cure Activator will be necessary in this case.
The provided text describes the 510(k) premarket notification for a dental adhesive named ADH19, comparing it to a predicate device, Scotchbond Universal.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for performance. Instead, it describes a "substantial equivalence" claim based on comparisons to a predicate device. The primary performance metric mentioned throughout is shear bond strength.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (ADH19) |
|---|---|---|
| Shear bond strength to enamel (self-etch & total-etch) | Comparable to Scotchbond Universal | Comparable to Scotchbond Universal |
| Shear bond strength to dentin (self-etch & total-etch) | Comparable to Scotchbond Universal | Comparable to Scotchbond Universal |
| Shear bond strength to various restoration materials (titanium, zirconia, NPM alloy, composite, high gold alloy, feldspathic glass ceramic, lithium disilicate) | Comparable to Scotchbond Universal | Comparable to Scotchbond Universal |
| Shear bond strength with RelyX Ultimate to enamel and dentin | Comparable to Scotchbond Universal | Comparable to Scotchbond Universal |
| Shear bond strength with different self-cure and dual-cure composites to enamel and dentin | Comparable to Scotchbond Universal | Comparable to Scotchbond Universal |
| Biocompatibility | Safe for its intended use, based on FDA guidance and international standards (e.g., ISO 10993 series) | Assessed by a board-certified toxicologist and concluded to be safe for its intended use. |
2. Sample size used for the test set and the data provenance
The document states that "In vitro testing was conducted to show the performance of ADH19 compared to the predicate device Scotchbond Universal regarding shear bond strength..." However, the sample size used for the test set is not specified. The data provenance is also not specified (e.g., country of origin, retrospective or prospective). It is an in vitro study, meaning it was conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable in the context of this submission. The "ground truth" for in vitro shear bond strength tests is the measured strength itself, not an expert assessment. For biocompatibility, a "board-certified toxicologist" assessed the product, but this isn't about establishing ground truth for individual test cases.
4. Adjudication method for the test set
This is not applicable as the study described is in vitro testing of physical properties, not a clinical study involving human assessment that would require adjudication.
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
There is no mention of an MRMC comparative effectiveness study or any AI component in this device submission. This is a dental material, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a dental adhesive, not an algorithm.
7. The type of ground truth used
For the shear bond strength tests, the "ground truth" is the measured physical property (shear bond strength) obtained through standardized in vitro testing methods (e.g., ISO 29022: 2013).
For biocompatibility, the "ground truth" is established through assessment against recognized international standards (ISO 10993 series) and FDA guidance, with the conclusion made by a board-certified toxicologist.
8. The sample size for the training set
This is not applicable. The device is a dental adhesive, not an algorithm or AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
§ 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.