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510(k) Data Aggregation
(15 days)
ORAVIVE TOOTH REVITALIZING PASTE
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 |
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