SPECIALTY APPLIANCES, LLC

Address:4905 HAMMOND INDUSTRIAL DRIVE,CUMMING,GA,30041,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) (10)

Premarket Exempt

Clear

Clear Image Aligner - D8197000150 Catalog Number :

Device Description : Series 4 - Single Arch Aligner

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner Prime: Upper - D8197000160 Catalog Number :

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner Prime: Lower - D8197000170 Catalog Number :

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner Prime: Dual - D8197000180 Catalog Number :

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000200 Catalog Number :

Device Description : Series 5 - Single Arch Aligner

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner Advanced: Upper - D8197000210 Catalog Number :

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner Advanced: Lower - D8197000220 Catalog Number :

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner Advanced: Dual - D8197000230 Catalog Number :

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000250 Catalog Number :

Device Description : Aligner G 1- Single Arch

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000300 Catalog Number :

Device Description : Aligner G 2- Single Arch

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

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