(132 days)
Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form that is used by the dental professional for etching dentin or enamel prior to tooth restoration.
Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a 510(k) clearance letter from the FDA for a dental etching product, "Premier Etch," confirming its substantial equivalence to legally marketed predicate devices. The letter primarily addresses regulatory compliance and device classification.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.
§ 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.