Clear Image Aligner

GUDID D8197000250

Orthodontic appliance system, progressive

Primary Device ID	D8197000250
NIH Device Record Key	98d9519d-f0b5-4586-bf9e-50ca6a2421b1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Clear Image Aligner
Version Model Number	700025
Company DUNS	106645484
Company Name	SPECIALTY APPLIANCES, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	D8197000250 [Primary]

NXC	Aligner, Sequential

Steralize Prior To Use	false
Device Is Sterile	false

D819702400	Aligner G 2- Dual Arch
D819702300	Aligner G 2- Single Arch
D819702200	Aligner G 1- Dual Arch
D819702100	70210
D819700610	Series 5 - Dual Arch Aligner
D819700600	Series 4 - Dual Arch Aligner
D819700510	Series 5 - Single Arch Aligner
D819700500	Series 4 - Single Arch Aligner
D819700420	Series 3 - Dual Arch Aligner
D819700410	70041
D819700400	Dual Arch Aligner
D819700320	Series 2 - Dual Arch Aligner
D819700310	Series 2 - Single Arch Aligner
D819700300	70030
D8197000250	Aligner G 1- Single Arch
D8197000100	Series 3 - Single Arch Aligner
D8197000000	Single Arch Aligner
D8197000700	700070
D8197000690	CIA Plus: Lower
D8197000680	CIA Select: Lower
D8197000670	CIA Plus: Upper
D8197000660	Clear Image Aligner Select: Upper
D8197000320	Series 10 - Dual Arch
D8197000310	Series 10 - Single Arch