(75 days)
GLUMA ONE BOND is a light curing single component enamel/dentin adhesive for onoming of all current brands of resin composite restorative materials and compomers. It also enhances adhesion to metals such as amalgam. GLUMA ONE BOND combines primer and adhesive in single bottle.
GLUMA ONE BOND is a one bottle adhesive, designed to bond resinous restorative materials to dental hard tissue. The product is a light curing monomer mixture dissolved in acetone which, following conditioning with phosphoric acid, is applied to enamel and dentin prior to co- polymerization with the restorative. The composition of GLUMA ONE BOND is based on three monomers which individually have been used in marketed dental products for decades. The hydrophilic hydroxyethylmethacrylate (HEMA) is essential for perfect wetting of and penetration into the conditioned tooth structure. Similarly, 4-MET(A) has hydrophilic and moieties for wetting and polymerization, whereas the urethane di-methacrylate monomer is responsible for formation of a cross-linked polymer network. The organic solvent acetone has the function of a carrier for the monomers while being an effective water chaser at the same time.
This document is a 510(k) submission for a dental adhesive, GLUMA ONE BOND, and therefore does not contain acceptance criteria or study details as typically found in medical device performance reports with quantitative metrics. The provided text is focused on demonstrating substantial equivalence to a predicate device, a regulatory pathway often used for low-risk devices.
Therefore, many of the requested categories for a rigorous performance study cannot be filled from the provided text.
Here's an attempt to extract what information is available and explain the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Bonding Performance | "performs better than or at least as good as the leading resinous bonding systems available in the market." | "Thorough in-vitro investigation has proven that the GLUMA ONE BOND performs better than or at least as good as the leading resinous bonding systems available in the market." |
| Ease of Use | Implied: Easy to use in a dental office setting. | "The results of a short-term clinical observation... confirms that the product is easy to use..." |
| Safety | Implied: Safe for use in dental procedures. | "The results of a short-term clinical observation... confirms that the product is... safe..." |
| Effectiveness | Implied: Effectively bonds restorative materials to dental hard tissue. | "The results of a short-term clinical observation... confirms that the product is... effective." |
| Metal Bonding | Implied: Ability to bond to non-precious dental alloys. | "GLUMA ONE BOND is also proven to bond to non-precious dental alloys, such as CoCr-based casting alloy and amalgam." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- In-vitro investigation: Not specified. The document only states "Thorough in-vitro investigation."
- Clinical observation: "some more than 300 restorations."
- Data Provenance:
- In-vitro investigation: Not specified (likely laboratory setting).
- Clinical observation: Conducted by eight dentists "under regular office conditions," implying a prospective, real-world, clinical setting. The country of origin is not specified but given the submitter's location (Indiana, USA) and the FDA review, it is likely US-based or at least compliant with US standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- In-vitro investigation: Not specified.
- Clinical observation: Eight dentists. Their specific qualifications (e.g., years of experience, specialization) are not detailed beyond being "dentists."
4. Adjudication Method for the Test Set
- Not applicable/Not specified. The clinical observation involved individual dentists assessing their own restorations, rather than a separate adjudication process for a centralized test set.
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
- Not applicable. This device is a dental adhesive, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a material device, not an algorithm. Its performance is inherent to the chemical and physical properties of the adhesive.
7. The Type of Ground Truth Used
- In-vitro investigation: Likely laboratory-based measurements of bond strength, durability, and other material properties (though specific metrics are not detailed).
- Clinical observation: Clinical outcomes (e.g., success/failure of restorations, ease of use feedback) as observed by the treating dentists. This is a form of expert observation/outcome data.
8. The Sample Size for the Training Set
- Not applicable. As a physical product, there is no "training set" in the context of an AI algorithm. Its development is based on chemical formulation and in-vitro/in-vivo testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is a manufacturing process and product development cycle, not an AI model development. The "ground truth" for its development would be established through chemical research, engineering principles, and iterative testing/formulation.
Summary of Limitations:
This 510(k) submission, particularly one from 1998 for a dental adhesive, predates modern detailed reporting requirements for AI/diagnostic devices. The information provided aligns with typical substantial equivalence claims for physical products, focusing on comparative performance against existing products and general clinical observations. It does not contain the granular detail about study design, statistical methods, or expert qualifications that would be expected for a complex diagnostic or AI-driven system today.
§ 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.