(15 days)
Oravive™ is a fluoride-free toothpaste product intended for cleaning the tooth surface on a daily basis. Clinical studies have shown that Oravive™ also provides relief from tooth sensitivity due to cold, heat, acids, sweets, or contact by the occlusion of dentin tubules.
Oravive™ is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® as its active ingredient. The non-aqueous formulation is designed to clean your teeth as well as give your whole mouth a fresh feeling we call REVITALIZING! Oravive™ is also designed to physically occlude dentin tubules for the management of sensitive teeth. NovaMin® (calcium sodium phosphossilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aquoous environment, NovaMin® undergoes a rapid surface reaction, allowing it 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for clinical performance in a quantifiable, pre-defined manner. Instead, it describes findings that support the device's efficacy and safety compared to controls and a predicate device. The performance claims are primarily related to reduction in tooth sensitivity and abrasivity.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility | No evidence of hazardous effects if used as directed. |
| Occlusion Efficacy (in vitro): Significant tubule occlusion compared to controls | Oravive™ occludes a statistically significant number of tubules compared to controls. |
| Abrasivity: RDA value |
§ 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.