(82 days)
Orthodontic Flowable Bracket Adhesive is a light cured composite designed for use in the indirect bonding technique and with lingual retainers, archwire stops, and Invisalign® attachments. It can also be used for occlusal build-ups. Its low viscosity and precise syringe delivery make it easy to place and finish, and adaptable to a variety of clinical situations.
Orthodontic Flowable Bracket Adhesive is a light cured composite designed for use in the indirect bonding technique and with lingual retainers, archwire stops, and Invisalign® attachments. It can also be used for occlusal build-ups. Its low viscosity and precise syringe delivery make it easy to place and finish, and adaptable to a variety of clinical situations.
This document is a 510(k) clearance letter from the FDA for an Orthodontic Flowable Bracket Adhesive. It does not contain information about acceptance criteria or a study proving device performance as requested. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
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§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.