DRAKE PRECISION DENTAL LABORATORY, INC.

Address:8510 Crown Crescent Ct,CHARLOTTE,NC,28227,US

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Filters

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

Concinnity Aligners - 00850028222003 Catalog Number :

Device Description : The Concinnity Aligners™ are a custom clear aligner system. They are a series of The Concinnity Aligners™ are a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as an alternative to traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment.Intended Use / Indications for Use:The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars).

Device Class : 2

Duns Number: 024484784

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

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