(64 days)
AdheSE One is a self-etching dental adhesive for direct light-curing of composite and compomer restorations. AdheSE One is contraindicated for use as an adhesive with dual-curing or self-curing composites. This products is also contraindicated for direct pulp capping.
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This document, K070646, is a 510(k) premarket notification for a dental device called AdheSE One, a self-etching dental adhesive. It contains a letter from the FDA determining substantial equivalence to a predicate device and an "Indications for Use" statement.
Unfortunately, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The document is a regulatory approval letter and an "Indications for Use" statement, not a scientific study report.
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§ 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.