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510(k) Data Aggregation
(70 days)
Alpha Bond Dentin/Enamel Bonding Agent is a single solution, hydrophilic, unfilled resin that acts both as a moist dentin primer and an adhesive and is primarily used as a Primer/bonding agent between the etched dentin and/or enamel surfaces and the Restorative composite material.
Alpha Bond Dentin/Enamel Bonding Agent is a single solution, hydrophilic, unfilled resin that acts both as a moist dentin primer and an adhesive.
I am sorry, but the provided text does not contain any information regarding acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Alpha Bond Dentin/Enamel Bonding Agent," indicating that the device is substantially equivalent to a predicate device.
To answer your request, I would need a different type of document, such as a clinical study report, a device validation report, or a regulatory submission that includes performance data and acceptance criteria.
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