(153 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Demonstrated Efficacy in Reducing Tooth Hypersensitivity | - Rapid and continual relief: Statistically significant reduction in VAS score for NovaMin® group compared to placebo (p |
§ 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.