(70 days)
BisBlock forms oxalate crystals which occlude the dentin tubules resulting in a reduction of sensitivity of teeth by applying:
- Prior to temporization (placement of provisional restorations).
- Prior to permanent cementation of indirect restorations.
- Prior to placement of direct restorations.
- When root surfaces are exposed.
BisBlock is an aqueous solution of oxalic acid in a semi-gel formulation. It is designed to be used on dentin etched with a phosphoric acid etchant prior to restoration of exposed dentin. It forms calcium oxalate crystals with dentin or bonds to the dentin. The crystals occlude the dentinal tubules opened with the etchant, which results in desensitization of natural dentition. The occlusion does not affect the following restoration.
This is a 510(k) premarket notification for a medical device (BisBlock) and does not involve AI/ML. Therefore, many of the requested categories are not applicable. The submission is for a dentin desensitizing agent, and the evaluation focuses on its substantial equivalence to a predicate device based on intended use, chemical composition, and physical properties, rather than performance metrics from a study involving AI.
Here's a breakdown of the provided information, addressing what is applicable and indicating what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (BisBlock) |
|---|---|
| Intended Use: Dentin Desensitizer | Intended Use: Dentin Desensitizer |
| Chemical Composition: Oxalate solution | Chemical Composite: Oxalate solution |
| Mechanical/Physical Properties: Forms crystals (calcium oxalate) occluding dentinal tubules. | Mechanical/Physical Properties: Blue semi-gel liquid that forms crystals (calcium oxalate) occluding dentinal tubules. |
| Biocompatibility: Non-toxic | Biocompatibility: Found to be non-toxic |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for a physical medical device (dental material), not an AI/ML device that generates performance data from a test set. The evaluation is based on comparison to an existing predicate device and non-clinical testing for biocompatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. No ground truth was established by experts for a test set in the context of an AI/ML device. The "ground truth" for this device would be its physical/chemical properties and efficacy as a desensitizer, demonstrated through laboratory tests and comparison to a predicate, not expert labeling of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a test set was mentioned, as it's not an AI/ML device study.
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. No MRMC study was conducted or mentioned because this is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility: The ground truth was based on established biocompatibility testing standards (the specific tests are not detailed but the result "non-toxic" is reported).
- For substantial equivalence: The ground truth was the characteristics and performance of the predicate device (Super Seal), which the applicant device aimed to match in terms of intended use, chemical composition, and mechanism of action.
8. The sample size for the training set
- Not Applicable. No training set was used, as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. No training set ground truth was established.
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.