(125 days)
- Direct dental restorations (e.g., resin-based composites, resin-modified glass ionomers, resin core build-ups, compomers).
- Indirect dental restorations (e.g., metal, resin-based composite, dental ceramics such as porcelain, pressed ceramic, lithium disilicate, lithium silicate or zirconia).
- Desensitization of dentin.
- Sealing of dentin, cementum or enamel.
The Parkell® Universal Adhesive is a single-component, one-bottle, light-cured universal bonding agent which utilizes proven 4-META and 10-MDP chemistry to enhance penetration into prepared enamel and dentin surfaces and to establish strong bonds to dental surfaces such as restorative composites, metals, dentin, enamel, cementum, and dental ceramics (e.g., porcelain, lithium disilicate, zirconia, or hybrid ceramics). The Device is useful for all direct and indirect dental restorations, desensitizing teeth, and sealing tooth structures against microleakage. Moreover, the Device can be used without prior acid-etching of dentin or cutting of enamel surfaces.
The Parkell® Universal Adhesive will be provided in a single bottle, with standard applicator brushes for applying the adhesive to treatment surfaces.
The provided document is a 510(k) premarket notification for the "Parkell® Universal Adhesive" and primarily focuses on demonstrating substantial equivalence to a predicate device, the "Scotchbond® Universal Adhesive."
Here's an analysis of the acceptance criteria and study information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the acceptance criterion for Shear Bond Strength is "at least about 6MPa" (denoted as "= 6 MPa | >= 6 MPa | >= 6 MPa |
| Dentin | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Silver alloy | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Cobalt-chrome alloy | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Porcelain, following acid etching | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Porcelain, following sandblasting | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Lithium disilicate, following sandblasting | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Lithium disilicate, following HF acid etching | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Zirconia, following sandblasting | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Composite Resin (self-cure) | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Composite Resin (light-cure) | >= 6 MPa | >= 6 MPa | >= 6 MPa |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for each shear bond strength test. It mentions that tests were performed "on a variety of dental substrates." The data provenance is not specified (e.g., country of origin, retrospective or prospective), but it's implied to be laboratory testing as part of a premarket notification for a dental adhesive.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study described is a laboratory performance test (shear bond strength) for a dental adhesive, not a study involving expert-derived ground truth. The "ground truth" here is the physical measurement of bond strength.
4. Adjudication method for the test set:
This information is not applicable for the same reason as 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 is not applicable. The device is a dental adhesive, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical product (dental adhesive), not an algorithm. The shear bond strength tests are a form of standalone performance evaluation for the physical properties of the adhesive.
7. The type of ground truth used:
The "ground truth" for the performance evaluation of the dental adhesive is based on physical measurement of shear bond strength in a laboratory setting, in accordance with ISO standards.
8. The sample size for the training set:
This is not applicable. The device is a physical product (dental adhesive), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This is 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.