(167 days)
This device is a one step no-mix adhesive for direct bonding of orthodontic bracket to tooth structure
The DMRC Self-Cure Bracket Adhesive One Step and Primer is a resin based adhesive designed for direct bonding of orthodontic brackets with no-mix step.
The document describes the DMRC Self-Cure Bracket Adhesive One Step and Primer and its substantial equivalence to a predicate device based on non-clinical testing.
Here's the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative sense with pass/fail thresholds. Instead, it presents the results of bench testing for the DMRC Self-Cure Bracket Adhesive One Step and Primer alongside the predicate device's performance to demonstrate "equivalence." The implied acceptance criterion is that the new device's performance is comparable to or better than the predicate device.
| Test Method | DMRC Self-Cure Bracket Adhesive and Primer (Reported Performance) | System 1+ and Activator (Ormco) (Predicate Device Performance) |
|---|---|---|
| Vicker's Hardness | 37 (5) | 29 (3) |
| Shear Bond Strength on enamel (MPa) | 6.7 (1) | 5.2 (0.7) |
| Self-Cure Set Time (min) | 2:30 | 2:00 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (e.g., number of specimens tested) for the Vicker's Hardness, Shear Bond Strength, or Self-Cure Set Time tests. It also does not explicitly mention the country of origin of the data or whether the data was retrospective or prospective. These were non-clinical bench tests, not human studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The "test set" here refers to non-clinical bench tests on materials, not a set of clinical cases requiring expert interpretation.
4. Adjudication Method for the Test Set:
Not applicable for non-clinical bench tests. The results are quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This product is a dental adhesive, and the evaluation was based on non-clinical material properties.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is the quantitative measurement obtained through standardized laboratory testing procedures for properties like Vicker's Hardness, Shear Bond Strength, and Self-Cure Set Time.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/machine learning device.
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.