(37 days)
As a Universal Self-Etching Adhesive System, ALL-IN-ONE Adhesive, as the name implies, is the only product one needs to etch, prime, and bond to a tooth structure and dental substrates.
ALL-IN-ONE is used for:
- Direct restorations (composite, amalgam)
- All indirect restorations (composite, metal, porcelain)
- Desensitization of crown preparations prior to impression making/provisionalization
- Composite core build-ups
- Composite to metal/set amalgam (direct veneering)
- Root desensitization
- New amalgam to existing amalgam
- Repairs (composite-to-composite, composite-to-porcelain)
As a Universal Self-Etching Adhesive System, ALL-IN-ONE Adhesive, as the name implies, is the only product one needs to etch, prime, and bond tooth structure. It is a twocomponent, single step adhesive system. ALL-IN-ONE is a light cure system that may be used for bonding both light-cure and self-cure composites, porcelain, and metal. ALL-IN-ONE may also be used for desensitization of tooth structures.
The provided document is a 510(k) Summary for a dental adhesive (ALL-IN-ONE) and describes its substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance data like an AI/ML device would. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance (Not applicable for this type of submission)
The document does not specify quantitative acceptance criteria or a reported device performance in the way an AI/ML device would, which might involve metrics like sensitivity, specificity, or AUC. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended use, chemical composition, and mechanical/physical properties.
| Property | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ALL-IN-ONE) |
|---|---|---|
| Intended use | Self-Etching, Single Step Dental Adhesive (PROMPT L-POP) | Self-Etching, Single Step Dental Adhesive |
| Multi-Step Dental Adhesive (ALL-BOND 2) | ||
| Chemical composition | Light-cure, unfilled, multifunctional methacrylate based resin (PROMPT L-POP) | Light-cure, unfilled, multifunctional methacrylate based resin |
| Dual-cure, unfilled, multifunctional methacrylate based resin (ALL-BOND 2) | ||
| Mechanical /physical properties | Low viscosity, yellow colored dental etching, priming, and bonding agent (PROMPT L-POP & ALL-BOND 2) | Medium viscosity, light pink colored dental etching, priming, and bonding agent |
| Oral Toxicity | Non-toxic | Non-toxic |
Explanation: The "acceptance criteria" here are implicitly met by demonstrating similar attributes to the predicate devices. The "reported device performance" is a description of ALL-IN-ONE's characteristics. The submission emphasizes that "side by side comparisons... clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices."
Study Details (Not applicable for this type of submission)
Since this is a submission for a dental adhesive demonstrating substantial equivalence, not an AI/ML device with performance studies, the following categories are not applicable and cannot be extracted from the provided text.
- Sample size used for the test set and the data provenance: Not applicable. No test set of clinical data from patients is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for a test set of clinical data is established.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the safety of the device was "oral toxicity testing" which found it to be non-toxic. For efficacy, the ground truth is established by its chemical and physical similarity and intended uses aligning with the predicate devices which are already deemed safe and effective.
- The sample size for the training set: Not applicable. No training set for an algorithm is discussed.
- How the ground truth for the training set was established: Not applicable.
§ 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.