(91 days)
A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.
Seity 37% Phosphoric Acid Etchant Gel
This document is a 510(k) clearance letter from the FDA for a dental etchant gel. It confirms that the device is substantially equivalent to legally marketed predicate devices.
This document describes a dental etchant gel, which is a chemical product, not a software device or an AI/ML-based medical device. Therefore, the questions regarding acceptance criteria, study details, sample sizes, ground truth, and AI/ML performance are not applicable to the information provided in this document.
The letter focuses on regulatory approval based on substantial equivalence to existing products, rather than performance studies as would be required for novel medical devices or AI/ML systems. No information about a study proving the device meets acceptance criteria in the context of an AI/ML device is present.
§ 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.