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 - D8197000310 Catalog Number :

Device Description : Series 10 - Single Arch

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000320 Catalog Number :

Device Description : Series 10 - Dual Arch

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000350 Catalog Number :

Device Description : Dual Arch Aligner

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000400 Catalog Number :

Device Description : Series 2 - Dual Arch Aligner

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner Refinement: Lower - D8197000420 Catalog Number :

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner Refinement: Dual - D8197000430 Catalog Number :

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000450 Catalog Number :

Device Description : Series 3 - Dual Arch Aligner

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000500 Catalog Number :

Device Description : Series 4 - Dual Arch Aligner

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000550 Catalog Number :

Device Description : Series 5 - Dual Arch Aligner

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000600 Catalog Number :

Device Description : Aligner G 1- Dual Arch

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

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