Clear Image Aligner

GUDID D8197000310

Series 10 - Single Arch

SPECIALTY APPLIANCES, LLC

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• Primary Device ID: D8197000310
• NIH Device Record Key: 55c4c6a3-3102-4c08-87e4-7e3320d36323
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clear Image Aligner
• Version Model Number: 700031
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	D8197000310 [Primary]

FDA Product Code

• NXC: Aligner, Sequential

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-19
• Device Publish Date: 2020-03-11

On-Brand Devices [Clear Image Aligner]

• 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