(115 days)
The indications of use of DREAMBOND are:
- all direct restorations
- all indirect restorations
- intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites)
- desensitizing/sealing of tooth structure
- protective varnish for glass ionomer fillings
- priming of enamel for orthodontic use
Bisco's DREAMBOND is a single-component dental bonding agent that combines etching, priming and bonding all in one bottle. DREAMBOND is an ethanol/water-based dental adhesive which bonds to dentin and to cut and uncut enamel. As a universal adhesive, DREAMBOND has been designed to work with light-cured, self-cured and dual-cured composite materials. DREAMBOND can be used for the bonding of both direct and indirect restorations. DREAMBOND may be used with or without phosphoric acid etchant.
The provided 510(k) summary for DREAMBOND is for a Resin Tooth Bonding Agent and not a medical imaging device or an AI-powered diagnostic tool. Therefore, the questions regarding acceptance criteria, study methodologies, and performance metrics for AI/ML-based devices are not directly applicable to this submission.
However, I can extract the relevant information regarding the device's performance based on the provided text, aligning the spirit of the questions to what is available.
Device: DREAMBOND (Resin Tooth Bonding Agent)
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly list "acceptance criteria" for performance in a tabular format as would be expected for a diagnostic device. Instead, it demonstrates substantial equivalence to predicate devices through comparisons of chemical composition and physical/mechanical properties. The overall acceptance criterion is "substantial equivalence" to the predicate devices.
| Feature / Property | Predicate Device (ACE Bond SE K063780) | DREAMBOND (Reported Performance) | Basis for Performance Claim |
|---|---|---|---|
| Chemical Composition | (Demonstrated Equivalence) | ||
| Light-cured | X | X | Comparison |
| Unfilled, multifunctional methacrylate resin | X | X | Comparison |
| Ethanol and water based adhesive | X | X | Comparison |
| Two component adhesive | X | DREAMBOND is single-component | |
| Single component adhesive | X | DREAMBOND is single-component | |
| Physical / Mechanical Property | (Demonstrated Equivalence) | ||
| Low viscosity | X | X | Comparison |
| Self-etching dental adhesive | X | X | Comparison |
| Total-etch dental adhesive | X | DREAMBOND feature | |
| Biocompatibility | Not explicitly listed for predicate | No mortality or toxicity observed | Oral Toxicity in Mice |
Overall Conclusion regarding performance (from submission): "The information provided in this 510(k) of DREAMBOND compared to ACE Bond SE demonstrates that DREAMBOND performs as well as or better than the predicate." And "DREAMBOND is safe for its intended use."
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text for physical/mechanical testing. For biocompatibility, it mentions "Oral Toxicity in Mice," but the number of mice is not stated.
- Data Provenance: The testing was conducted "in the lab using ISO, ADA/ANSI, and Bisco Inc. QA/QC and R&D test protocols." This implies internal laboratory testing, likely based in Schaumburg, IL, USA. The data is retrospective in the sense that it's laboratory test results rather than clinical trial outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a dental bonding agent, and its performance (e.g., bond strength, viscosity) is measured through objective physical and chemical tests, not through expert interpretation of images or clinical assessments that require "ground truth" and expert consensus in the context of diagnostics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the reasons stated in point 3.
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
This question is not applicable. This is not an AI/ML-based diagnostic device or a device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an AI/ML device. The "standalone" performance would refer to the physical and mechanical properties of the bonding agent itself, which were tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be established by the results of standardized physical, chemical, and biological tests (e.g., ISO, ADA/ANSI standards for bond strength, viscosity, biocompatibility). It is based on objective laboratory measurements rather than clinical ground truth obtained from human experts or pathology.
8. The sample size for the training set
This question is not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
This question is not applicable. This is not an AI/ML 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.