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 - D8197000650 Catalog Number :

Device Description : Aligner G 2- Dual Arch

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000660 Catalog Number :

Device Description : Clear Image Aligner Select: Upper

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000670 Catalog Number :

Device Description : CIA Plus: Upper

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000680 Catalog Number :

Device Description : CIA Select: Lower

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000690 Catalog Number :

Device Description : CIA Plus: Lower

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner - D8197000700 Catalog Number :

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner Select (Z-FLX): Upper - D8197000800 Catalog Number :

Device Description : Clear Image Aligner Select (Z-FLX): Upper

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner Select (Z-FLX): Lower - D8197000810 Catalog Number :

Device Description : Clear Image Aligner Select (Z-FLX): Lower

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner Select (Z-FLX): Dual - D8197000820 Catalog Number :

Device Description : Clear Image Aligner Select (Z-FLX): Dual

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Clear Image Aligner Plus (Z-FLX): Upper - D8197000830 Catalog Number :

Device Description : Clear Image Aligner Plus (Z-FLX): Upper

Device Class : 2

Duns Number: 106645484

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

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