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Provides rapid and continual relief from tooth hypersensitivity-dueto cold, heat, acids, sweets, or contact through its action of the occlusion of dentin tubules.

Oralief™ Therapy for Sensitive Teeth incorporates NovaMin® as its active ingredient. The unique brushing regimen and NovaMin® -containing formulation provide rapid and continual relief from tooth sensitivity. NovaMin® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® rapidly releases mineral-building ions, allowing it to relieve from sensitivity by physically occluding dentin tubules. Within a short period of time, essentially all of the NovaMin® reacts to form a mineral layer which is chemically and structurally similar to natural tooth mineral.

The provided document describes the FDA 510(k) premarket notification for Oralief™ Therapy for Sensitive Teeth. This product is a dentifrice (toothpaste) containing NovaMin® as its active ingredient, intended to provide relief from tooth hypersensitivity by occluding dentin tubules.

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Acceptance Criteria and Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of a predefined threshold for statistical metrics (e.g., sensitivity, specificity). Instead, the acceptance criterion for the device seems to be demonstrated efficacy in reducing tooth hypersensitivity compared to a placebo, and substantial equivalence to a legally marketed predicate device (Butler GUM® Prophylaxis Paste with NovaMin®).

The reported device performance is based on the clinical study described.

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