(29 days)
As a Universal Self-Etching Adhesive System, ACE BOND SE, as the name implies, is the only product one needs to etch, prime, and bond to a tooth structure and dental substrates.
ACE BOND SE is used for:
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- Direct restorations (composite, amalgam)
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- All indirect restorations (composite, metal, porcelain)
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- Desensitization of crown preparations prior to impression making/provisionalization
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- Composite core build-ups
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- Composite to metal/set amalgam (direct veneering)
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- Root desensitization
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- New amalgam to existing amalgam
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- Repairs (composite-to-composite, composite-to-porcelain)
ACE BOND SE is a light-cured all-in-one bending agent that combines etching, priming and bonding into one single step. ACE BOND SE is an ethanol/water-based, two-component, single step adhesive system.
This submission pertains to a dental adhesive device, ACE BOND SE. The information provided is for a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device rather than strictly defining acceptance criteria through a formal study with statistical targets for performance.
Here's an analysis based on the provided text, focusing on how the device "meets acceptance criteria" in the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
In a 510(k) submission where substantial equivalence is claimed through comparison to a predicate device, the "acceptance criteria" are implicitly that the new device performs similarly enough to the predicate device in relevant aspects, and that any differences do not raise new questions of safety or effectiveness. The study presented here is a comparative analysis rather than a performance target.
| Property | Acceptance Criteria (Implied by Predicate - ALL-IN-ONE) | Reported Device Performance (ACE BOND SE) |
|---|---|---|
| Intended Use | Self-Etching, Single Step Dental Adhesive | Self-Etching, Single Step Dental Adhesive |
| Chemical Composition | Light-cure, unfilled, multifunctional methacrylate-based resin. | Light-cure, unfilled, multifunctional methacrylate-based resin. |
| Mechanical/Physical Properties | Medium viscosity, light pink colored dental etching, priming, and bonding agent. | Low viscosity, pink colored dental etching, priming, and bonding agent. |
| Toxicity | Non-toxic (implied by predicate device clearance) | Non-toxic (explicitly stated) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a numerical sample size for the tests conducted to demonstrate equivalence for ACE BOND SE.
The text states: "Side by side comparisons of ACE BOND SE to the device ALL-IN-ONE clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device." and "ACE BOND SE was tested for oral toxicity and was found to be non-toxic."
- Test Set Sample Size: Not specified.
- Data Provenance: Not explicitly stated, but assumed to be from in vitro laboratory testing given the nature of a dental adhesive and the properties compared (chemical composition, physical properties, toxicity). Details like country of origin or whether the tests were retrospective/prospective are not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information is generally not applicable to a 510(k) submission for a dental adhesive where substantial equivalence is demonstrated through comparative material properties and toxicity testing. The "ground truth" here is defined by the established properties and safety profile of the predicate device (ALL-IN-ONE) and the laboratory standards for chemical/physical testing and toxicity assessment. There isn't a "ground truth" established by experts in the sense of clinical image interpretation or diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. The comparisons are based on objective material property measurements and toxicity testing, not on subjective assessments requiring adjudication among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are typically used for diagnostic imaging devices to assess human reader performance with and without AI assistance. This device is a dental adhesive, and its performance is evaluated through material science and toxicology, not by human reader interpretation of cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a material (dental adhesive), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Material Science Data: Objective measurements of chemical composition, viscosity, and color.
- Toxicity Testing: Laboratory results demonstrating non-toxicity.
- Predicate Device Profile: The established safety and effectiveness profile of the ALL-IN-ONE adhesive, which serves as the benchmark for equivalence.
8. The Sample Size for the Training Set
Not applicable. Training sets are relevant for machine learning algorithms. This submission is for a physical dental adhesive, not an AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8.
§ 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.