New England Orthodontic Lab

Address:3 Riverside Dr,Andover,MA,01810,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Aligner, Sequential (NXC) (1)

Premarket Exempt

Clear

NEOLab Clear Aligners - 00810064700002 Catalog Number : 1021

Device Description : A series of preformed teeth aligners or positioners, worn in succession and chan A series of preformed teeth aligners or positioners, worn in succession and changed every few weeks, designed to influence the shape and/or function of the stomatognathic system; often used to impact a patient's appearance and self image. It is typically custom-made using computer-generated modelling based on an initial oral impression, and a consultation with an orthodontist. It is typically made of a clear hard plastic, e.g., a thermoformed polycarbonate (PC). It is typically used to correct malocclusions such as underbites, overbites, cross bites and open bites, or crooked teeth and various other flaws of teeth and jaws, whether cosmetic or structural. This is a single-use device.

Device Class : 2

Duns Number: 050620384

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

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