(14 days)
Butler Nucare® Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that Butler Nucare® Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.
Butler Nucare® Root Conditioner with NovaMin® is a biologically-compatible device designed to condition exposed tooth roots and to physically occlude dentin tubules for the management of sensitive teeth. Butler Nucare Root Conditioner with NovaMin® is an aqueous suspension of an inorganic particulate, NovaMin® (calcium sodium phosphosilicate), composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically adhere to exposed root dentin and to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
The information provided describes a 510(k) premarket notification for a dental device, focusing on its substantial equivalence to a predicate device rather than a new clinical study establishing specific acceptance criteria and performance against those criteria. Therefore, much of the requested information regarding acceptance criteria, study design details, and performance metrics for a novel AI device is not available in the provided text.
Based on the provided information, here's what can be extracted and what is not available:
Acceptance Criteria and Reported Device Performance
The provided text does not present explicit numerical acceptance criteria for device performance as would be expected for a novel AI device. Instead, the focus is on demonstrating "substantial equivalence" to a predicate device and showing efficacy in specific in vitro tests.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: No hazardous effects to the patient. | The results of cytotoxicity, intracutaneous irritation, maximization, and acute systemic toxicity tests indicate no evidence of any hazardous effects to the patient if the product is used as directed. |
| Tubule Occlusion Efficacy: Occlusion of exposed dentinal tubules. | An in vitro dentin block model study indicated that Butler Nucare® Root Conditioner with NovaMin® occludes a statistically significant number of tubules when compared with both positive and negative controls. (No specific percentage or quantitative measure is provided for the occlusion.) |
| Substantial Equivalence: Similar technological characteristics and intended use to predicate device. | The device is considered substantially equivalent to Quell™ Desensitizer (K010957). Both are designed to relieve hypersensitivity by depositing a calcium phosphate layer to occlude dentin tubules. Differences in the form of calcium/phosphate delivery (bioactive glass vs. solution) are noted. |
Study Details (as far as available for this type of submission)
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Sample size used for the test set and the data provenance:
- Biocompatibility Studies: Not specified, but standard in vivo and/or in vitro models would have been used for cytotoxicity, intracutaneous irritation, maximization, and acute systemic toxicity. Data provenance is not mentioned.
- Tubule Occlusion Efficacy Study: An "in vitro dentin block model" was used. The number of dentin blocks or samples is not specified. Data provenance is not mentioned. This is an in vitro study, not typically subject to geographical provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this type of submission. The studies described are laboratory-based (biocompatibility and in vitro efficacy), not involving expert-derived ground truth as in imaging or diagnostic AI.
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Adjudication method for the test set:
- Not applicable. The reported studies are experimental measurements (e.g., cell viability for cytotoxicity, physical measurements for tubule occlusion), not requiring human adjudication.
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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:
- No. This is not an AI device, and no MRMC study was conducted.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The performance studies evaluate the physical and biological effects of the product itself.
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The type of ground truth used:
- Biocompatibility: Measured biological endpoints (e.g., cell survival, skin reaction, systemic toxicity) based on established laboratory test methods.
- Tubule Occlusion Efficacy: Direct measurement of tubule occlusion in an in vitro model (e.g., microscopy). The "ground truth" here is the objective physical state of the tubules after treatment.
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The sample size for the training set:
- Not applicable. This is not an AI device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.