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This device is indicated for direct dental bonding applications.

3M™ Dent System II Plus is a two part, radiopaque dual-curing luting composite. This device, as well as the predicate devices, are based on methacrylate resin chemistry. The 3M™ Dent System II Plus Paste A alone can be cured by exposure to a dental visible light curing unit. When Pastes A and B are mixed, the material will chemically cure without exposure to light or can be cured by exposure to visible light.

The provided text does not contain information about acceptance criteria for a medical device or a study proving that a device meets such criteria. Instead, it is a 510(k) summary and an FDA clearance letter for a dental product called "3M™ Dent System II Plus."

The document primarily focuses on:

• Identification of the device: 3M™ Dent System II Plus, a two-part, radiopaque dual-curing luting composite.
• Intended Use: Used in conjunction with a dental adhesive system to bond direct and indirect restorations.
• Predicate Devices: 3M™ Scotchbond™ Resin Cement, Bisco Resinomer™, Bisco Duolink™.
• Technological Characteristics: Based on methacrylate resin chemistry, similar to predicate devices.
• Evidence of Substantial Equivalence: Demonstrated through "comparative results of the bench tests conducted." These tests include:
  • Shear bond strength
  • Compressive strength
  • Diametral tensile strengths
  • Film thickness

The document does not provide the following information from your request:

1. A table of acceptance criteria and the reported device performance: While specific bench tests are mentioned (shear bond strength, compressive strength, etc.), the document does not list the acceptance criteria for these tests (e.g., minimum shear bond strength required) nor the actual performance values achieved by the 3M™ Dent System II Plus. It only states that the results "validated" similar technological characteristics and that the device "performs as well or better than the predicate devices."
2. Sample size used for the test set and the data provenance: No information is given about the sample sizes for the bench tests or where the data came from.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As this is a dental cement, "ground truth" in the context of clinical expert review is not applicable here. The performance is assessed via laboratory bench tests.
4. Adjudication method for the test set: Not applicable for bench tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a dental cement, not an imaging or diagnostic device requiring human reader interpretation.
6. If a standalone performance (algorithm only) was done: Not applicable, as this is a physical dental product, not a software algorithm.
7. The type of ground truth used: For a dental cement, "ground truth" is typically defined by objective physical and mechanical properties measured in a laboratory (e.g., actual bond strength, actual compressive strength). The document only generally refers to the results of "bench tests."
8. The sample size for the training set: Not applicable, as this refers to a physical product and not a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

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