(46 days)
This device is intended to be used for the prescribed treatment of malocclusions by dentists. The device is used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 2 to 4 weeks when they are replaced.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "Power Coins Glow in the Dark Ligatures." It grants clearance for the device to be marketed. However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The letter focuses on the regulatory clearance process, stating that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions. It does not delve into specific performance metrics, clinical studies, or technical evaluations.
Therefore, I cannot provide the requested table and study details based on the input text.
§ 872.5410 Orthodontic appliance and accessories.
(a)
Identification. An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.