(5 days)
· To reduce pain in exposed cervical areas not requiring restoration.
· To alleviate dentinal sensitivity after preparation of teeth to receive indirect or direct restorations.
DenMat Glutaraldehyde Desensitizer is an aqueous, 5% glutaraldehyde-based desensitizer with 35% Hydroxy-ethyl Methacrylate (HEMA - a pre-primer resin) designed for use with 4th and 5th generation adhesives. DenMat Glutaraldehyde Desensitizer works by coagulating the plasma proteins contained within the dentinal tubule fluid. This coagulation forms an initial "plug" (which can be seen to a depth of 200 microns), eliminating the movement of fluid within the tubules-the root cause of dentinal sensitivity.
The provided text describes the 510(k) summary for the DenMat Glutaraldehyde Desensitizer, which is a dental product. The submission aims to demonstrate substantial equivalence to a predicate device, GLUMA Desensitizer. The study described focuses on bench performance testing rather than clinical trials with human subjects or AI algorithms.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are presented implicitly by comparing the proposed device's performance to the predicate device and established technical specifications for dental desensitizers.
| Property or Characteristic | Acceptance Criteria (from Predicate/Technical Manual) | Reported DenMat Glutaraldehyde Desensitizer Performance | Meets Criteria? |
|---|---|---|---|
| Viscosity (η) | Between 2-4 cps (based on a typical desensitizer composition and water viscosity) | 2.902 ± 0.09 cps (Average ± SD) | Yes |
| pH | 3.2 - 4.4 (to ensure dentin integrity); GLUMA pH range: 3-4 | 3.563 ± 0.006 (Average ± SD) | Yes |
| Shear Bond Strength | Does not adversely affect bond strengths of resin cement to dentin (based on predicate device information and general knowledge) | Average increase from 8.49 MPa (without) to 10.32 MPa (with desensitizer); "does not interfere bonding" | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Viscosity Test Set: 3 measurements
- pH Test Set: 3 measurements
- Shear Bond Strength Test Set: 9 specimens were tested both with and without the DenMat Glutaraldehyde Desensitizer.
- Data Provenance: The tests were non-clinical (bench performance testing) conducted by Den-Mat Holdings, LLC. The text does not specify the country of origin for the raw materials or testing facility, but it is implied to be within the company's control. It is retrospective in the sense that the predicate device's data (GLUMA) is referenced for comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This study involves non-clinical bench testing of physical and chemical properties, not human-read medical images or clinical outcomes requiring expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The tests are quantitative measurements of physical and chemical properties.
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 is a non-clinical bench study for a dental desensitizer, not an AI-powered diagnostic device involving human readers or comparative effectiveness studies with AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this study is based on:
- Established Technical Specifications: For viscosity (2-4 cps) and pH (3.2-4.4), derived from general knowledge of dental materials and the predicate device's characteristics.
- Predicate Device Performance: Direct comparison to GLUMA Desensitizer's reported viscosity (2.95 ± 0.07 cps) and pH (3.59 ± 0.01).
- Scientific Literature/Clinical Studies (referenced): Supporting the mechanism of action and the non-interference with bond strength. For example, reference 5 states, "Glutaraldehyde has shown little or no effect on retention on crowns luted with zinc phosphate, glass ionomer, and resin-modified glass ionomer cements*, and is one of few desensitizers that will not adversely affect bond strengths of resin cement to dentin."
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning study that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, there is no training set. The "ground truth" (acceptance criteria) for the performance tests was established through existing scientific literature, technical specifications for similar products, and direct comparative testing against the predicate 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.