(229 days)
To relieve dental hypersensitivity caused by bleaching procedures, cold, heat, acids, or sweets.
ReminGel is a convenient, premixed, ready-to-use, opaque aqueous-based gel. ReminGel consists of suspended hydroxyapatite and calcium and phosphate salts that help restore a tooth's hydroxyapatite structure through remineralization. This remineralization results in tubule occlusion and blocks fluid flow in dentinal tubules, thereby relieving dentinal sensitivity. ReminGel blocks nerve excitability through potassium release. ReminGel is packaged in a 3oz (90mL) tube. ReminGel is for prescription use (Rx) and over-the-counter (OTC) use. ReminGel can be applied to teeth using dental appliances (e.g. fluoride tray, whitening tray, periotray, etc.) or via a toothbrush.
Here's a breakdown of the acceptance criteria and study information for ReminGel, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Anticipated Performance) | Reported Device Performance (ReminGel) |
|---|---|
| Tubule Occlusion: Visibly occlude dentinal tubules to inhibit dentin sensitivity. | Visibly occluded dentinal tubules, demonstrating inhibition of dentin sensitivity. (Identical to predicate device Super Seal) |
| Shelf-Life: Minimum of 2 years. | 2 years (determined through accelerated shelf-life testing; real-time aging ongoing). |
| Transit Performance: Withstand simulated transit conditions. | Performed satisfactorily post-transit, confirming no negative effect on the product. |
| Cytotoxicity: Demonstrate acceptable levels of biocompatibility. | Yielded better cytotoxicity results compared to the predicate device, SuperSeal. |
| Irritation: Be a non-irritant. | Found to be a non-irritant. |
| Sensitization: Be a non-sensitizing agent. | Found to be a non-sensitizing agent. |
Study Details
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Sample Size used for the test set and data provenance:
- Tubule Occlusion Testing: Resected human teeth were used. The exact sample size ("N") is not specified.
- Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization): Not specified in terms of human subjects or teeth. These are in vitro and in vivo tests, typically performed on cell cultures or animal models for initial screening (as per ISO 10993 standards listed). The document does not provide details on the specific samples used for these tests.
- Shelf-Life Testing: Not specified.
- Transit Testing: Not specified.
- Data Provenance: Not explicitly stated, but based on the in vitro nature of the tubule occlusion study on "resected human teeth," it implies laboratory testing rather than a clinical trial in patients. The biocompatibility tests are also laboratory-based. It is retrospective in the sense that the results were gathered and submitted as part of the 510(k) submission, not a prospective clinical trial.
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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/Not specified. The studies cited are non-clinical (laboratory/bench testing). For tubule occlusion, the "ground truth" would be the visible occlusion as observed through microscopy, which doesn't directly involve multiple expert adjudicators for "truth" establishment in the way clinical images would.
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Adjudication method for the test set:
- Not applicable. As the studies are non-clinical, there is no expert adjudication method like 2+1 or 3+1 typically used for clinical image interpretation.
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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 MRMC study was conducted. This device (ReminGel) is a medical product (cavity varnish) and not an AI/software-as-a-medical-device that would typically involve human readers and AI assistance for interpretation.
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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 algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Tubule Occlusion: Visual observation of dentinal tubule occlusion (likely microscopic evaluation).
- Shelf-Life: Measured physical and chemical properties over time.
- Transit, Cytotoxicity, Irritation, Sensitization: Results from standardized laboratory test methods (e.g., ISO 10993 series).
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The sample size for the training set:
- Not applicable. This is a medical product, not a machine learning/AI model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
Overall Context: The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Super Seal) and a reference device (Senzzzz Away) through non-clinical performance and biocompatibility testing, rather than extensive clinical efficacy trials. Clinical performance was explicitly "not deemed necessary" for this submission, likely due to the established mechanism of action and similarity to legally marketed devices.
§ 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.