(85 days)
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- Fabrication of temporary crowns, bridges, inlays, onlays and veneers
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- Fabrication of long-term temporary restorations
MSN-006 is a dual-cured, temporary crown and bridge resin. The components consists of Paste A and B, which are filled in a cartridge. Both pastes are automixed with a mixing tip.
This is a 510(k) summary for a dental device, MSN-006, a temporary crown and bridge resin. The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through bench testing against an international standard. As such, it does not involve AI or algorithms, human readers, or clinical studies with ground truth established by experts or pathology.
Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information provided in this document.
However, I can provide the acceptance criteria and performance based on the bench testing described.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by the international standard ISO 10477: 2004 (Dentistry - Polymer-based crown and bridge materials). The document states that the applicant device (MSN-006) complies with all the requirements of this standard. While specific numerical acceptance criteria from ISO 10477 are not explicitly listed in the document, it broadly states that "Differences in bench top performance tests meet or exceed requirements as outlined in ISO 10477". It also notes "Differences in Flexural Strength, Water Sorption and Solubility are noted" but still confirms compliance with ISO 10477.
| Characteristic | Acceptance Criteria (from ISO 10477) | Reported Device Performance (MSN-006) |
|---|---|---|
| Flexural Strength | Meets ISO 10477 requirements | Meets or exceeds ISO 10477 requirements (differences noted but compliant) |
| Water Sorption | Meets ISO 10477 requirements | Meets or exceeds ISO 10477 requirements (differences noted but compliant) |
| Solubility | Meets ISO 10477 requirements | Meets or exceeds ISO 10477 requirements (differences noted but compliant) |
| Other characteristics of polymer-based crown and bridge materials | Meets ISO 10477 requirements | Complies with all requirements of ISO 10477 |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a bench top testing regimen. The document explicitly states: "Bench top testing indicates that even with different formulas, applicant device and predicate devices previously mentioned, meet specifications listed in ISO 10477 (Section 18)." and "In summary, indications for previously mentioned predicate devices and applicant device are the same. Differences in bench top performance tests meet or exceed requirements as outlined in ISO 10477 (Section 18)."
Remaining Information (Not Applicable to this Document):
2. Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant here.
4. Adjudication method for the test set: Not applicable.
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 not an AI/algorithm-based device.
6. If a standalone (i.e., 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: Not applicable. For bench testing, the "ground truth" is adherence to the scientific and technical specifications of the ISO standard.
8. The sample size for the training set: Not applicable. This is not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/algorithm-based device.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.