(297 days)
Prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.
BioMin® Restore Plus is a daily-use, prescription fluoride dentifrice use in the prevention and treatment of dental sensitivity through physical occlusion of dentin tubules. The formulation incorporates BioMin™ F (Calcium Fluoro-Phosphosilicate, a particular form of bioactive glass) as its active ingredient. When exposed to an aqueous environment, BioMin™ F undergoes a rapid surface reaction to form Fluorapatite, which is chemically similar to natural tooth mineral, allowing it to physically occlude tubules.
The provided text is a 510(k) summary for the device "BioMin® Restore Plus," a fluoride dentifrice intended to prevent and treat dental sensitivity by occluding dentin tubules. Here's a breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for "BioMin® Restore Plus" are primarily based on its ability to perform comparably to its predicate devices in terms of dentin tubule occlusion and safety (abrasivity).
| Acceptance Criteria Item | Reported Device Performance |
|---|---|
| Dentine Tubule Occlusion Effectiveness | "BioMin® Restore Plus is as effective as the primary predicate device at dentine tubule occlusion." |
| Relative Dentin Abrasivity (RDA) | "The Relative Dentin Abrasivity (RDA) value is similar to the primary predicate and is well under the limit considered safe for daily use ( |
§ 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.