(79 days)
The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.
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I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, sample size, ground truth establishment, or any studies conducted for the Morales Protraction Facemask. The document is an FDA 510(k) premarket notification letter, which primarily focuses on the substantial equivalence of the device to legally marketed predicate devices and administrative details like regulation numbers and contact information. It does not contain the detailed technical or clinical study data you are asking for.
§ 872.5500 Extraoral orthodontic headgear.
(a)
Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.(b)
Classification. Class II.