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510(k) Data Aggregation
(297 days)
Dr. Collins, Inc.
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 ( |
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(325 days)
Dr. Collins, Inc.
Restore Toothpaste is a fluoride-free toothpaste intended for cleaning the tooth surface on a daily basis. The toothpaste is formulated to provide rapid and continual desensitization through mechanical occlusion of exposed dentinal tubule.
Not Found
This document is an FDA clearance letter for "Restore Toothpaste" (K181965). It confirms the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria. The letter refers to a "premarket notification" and states that the FDA "reviewed your Section 510(k) premarket notification," meaning the manufacturer submitted data, but the content of that data and the study details are not present in these pages.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document is solely an FDA clearance letter and does not contain the technical study details requested.
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