(223 days)
HurriSeal® is a desensitizer with fluoride and benzalkonium chloride to be applied prior to restorative procedures by the dental professional.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a product named "Hurriseal® Dentin Desensitizer." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this type of document (a 510(k) clearance letter) typically does not contain the detailed information required to answer your questions about acceptance criteria and a study proving those criteria were met.
A 510(k) submission generally involves demonstrating substantial equivalence rather than conducting large-scale clinical trials with acceptance criteria for device performance in the way you've described for AI/diagnostic devices. For devices like a dentin desensitizer, the evidence for substantial equivalence often relies on:
- Comparison to a predicate device: Showing similar technological characteristics, materials, and intended use.
- Bench testing: In vitro studies to confirm material properties, strength, or specific desensitizing mechanisms.
- Limited clinical data (if necessary): Small studies might be conducted if there are novel aspects, but typically not a full-blown comparative effectiveness study with AI-like metrics.
Therefore, I cannot provide the requested information based on the text provided. To answer your questions, one would need access to the full 510(k) submission document or a separate clinical study report for the Hurriseal® Dentin Desensitizer, which is not part of this letter.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.