Search Results
Found 1 results
510(k) Data Aggregation
(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 (<250) established by American Dental Association (ADA)." The specific RDA value is not provided but stated to be <250. |
| Biocompatibility | "The results of these tests and studies indicate there is no evidence of any hazardous effects and the subject device is safe for its intended use." (This implies meeting established biocompatibility standards like ISO10993). |
| Technological Characteristics | The fundamental principle and mode of action (physical occlusion of dentin tubules via apatite layer formation) of BioMin® Restore Plus is the same as the predicate devices. The active ingredients are compositionally and structurally very similar to the primary predicate device. The reference device differs slightly due to containing pre-formed hydroxyapatite particles for direct tubule occlusion, but the overall principle is considered substantially equivalent. |
| Intended Use | "For dental hypersensitivity relief" (matches predicate devices). |
| Indications for Use | "Prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity." (Equivalent to predicate devices although the primary predicate is OTC and the subject device is prescription, this difference is noted but deemed not to affect substantial equivalence in this context). |
| Design | "Paste/gel that is applied to the tooth using an applicator brush or similar application." (Matches predicate devices). |
| Composition of Material | Composing ingredients (filler, surfactant, thickening agent, colorant, sweetener & flavor enhancer) are exact same as primary predicate, differing only in active ingredients which are still compositionally and structurally very similar apatite-forming ingredients. The reference device also contains hydroxyapatite. |
| Principle of Action | "Occlude dentin tubules through reaction with saliva and subsequent formation of apatite layer." (Matches primary predicate. Reference device also has this principle but additionally features direct occlusion with pre-formed hydroxyapatite particles, a slight difference but still considered substantially equivalent). |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The formula of BioMin® Restore Plus was tested for its ability to reduce dentine hypersensitivity through physical occlusion of dentine tubule and its relative abrasion level of dentine and enamel."
- Sample Size for Test Set: The document does not specify the sample size used for the dentine tubule occlusion test or the Relative Dentin Abrasivity (RDA) test.
- Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that "Biocompatibility" tests were performed "in accordance with ISO10993."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information about the number of experts, their qualifications, or their involvement in establishing ground truth for the performance tests. The performance tests appear to be laboratory-based evaluations rather than expert consensus-driven clinical assessments.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method as the reported performance tests are laboratory-based and yield measurable outcomes (e.g., occlusion effectiveness, RDA values) rather than subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The device is a dentifrice, not an imaging or diagnostic AI device that typically involves human readers.
6. Standalone Performance Study
The reported "Performance Tests" describe the standalone performance of the BioMin® Restore Plus formula in terms of its ability to occlude dentin tubules and its abrasivity. These tests evaluate the algorithm/device's effect independently.
- "The dentine tubule occlusion test result indicates that BioMin® Restore Plus is as effective as the primary predicate device at dentine tubule occlusion."
- "Meanwhile, the Relative Dentin Abrasivity (RDA) value is similar to the primary predicate and is well under the limit considered safe for daily use (<250) established by American Dental Association (ADA)."
7. Type of Ground Truth Used
The ground truth for the performance tests appears to be established through scientific measurements and widely accepted dental standards:
- Dentin Tubule Occlusion: The "ground truth" would likely be based on objective in-vitro or in-situ measurements (e.g., using microscopy) of the extent of tubule occlusion, compared against the predicate device's performance.
- Relative Dentin Abrasivity (RDA): The "ground truth" is defined by a quantitative measurement of abrasivity, compared against an established safety limit (<250) set by the American Dental Association (ADA).
- Biocompatibility: The "ground truth" for safety is established by adherence to recognized international standards such as ISO10993.
8. Sample Size for the Training Set
The document does not mention a "training set" as this is not a machine learning or AI-driven device in the context of typical AI medical device submissions. The "formula" and "active ingredient" are tested for their inherent properties.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the question of how its ground truth was established is not applicable to this submission.
Ask a specific question about this device
Page 1 of 1