(57 days)
Oralief™ OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules
Oralief™ OTC Toothpaste for Sensitive Teeth is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® (calcium sodium phosphosilicate) as its active ingredient. The non-aqueous formulation is designed to clean teeth as well as to physically occlude dentin tubules for the reduction of tooth sensitivity. When exposed to an aqueous 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 an analysis of the provided text regarding the acceptance criteria and supporting studies for Oralief™ OTC Toothpaste for Sensitive Teeth, structured to address your specific points:
Since this is a submission for a toothpaste (a medical device in this context), the "acceptance criteria" and "performance" are typically measured against established safety standards (like abrasivity limits) and functional claims (like tubule occlusion efficacy), rather than diagnostic accuracy metrics. There isn't a direct "acceptance criteria" table in the form you might expect for a diagnostic AI device, so I will synthesize it from the provided safety and performance data.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Claim | Reported Device Performance |
|---|---|
| Safety - Biocompatibility | No evidence of any hazardous effects to the patient if the product is used as directed. |
| Safety - Abrasivity (RDA Value) | Mean Radioactive Dentin Abrasion (RDA) value of 125.55. |
| - Acceptable Limit (Implicit) |
§ 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.