Frankel

GUDID 00889989038460

Frankel

ALLESEE AOA-PRO

Orthodontic palate expander/teeth aligner, self-removable

• Primary Device ID: 00889989038460
• NIH Device Record Key: b05fd551-8992-4693-800f-a97b149d1841
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Frankel
• Version Model Number: 3000-0013
• Company DUNS: 158312728
• Company Name: ALLESEE AOA-PRO
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com
• Phone: +12628861050
• Email: more.information@aoalab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889989038460 [Primary]

FDA Product Code

• KMY: POSITIONER, TOOTH, PREFORMED

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: 2023-03-21
• Device Publish Date: 2023-03-13

Devices Manufactured by ALLESEE AOA-PRO

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• 10889989087649 - Archwire Extender Accessory, Size .022, Cast Body, Pk of 10: 2023-04-13 Archwire Extender Accessory, Size .022, Cast Body, Pk of 10
• 00889989087659 - Herbst Hanks Telescoping Accessories: 2023-04-13 Herbst Hanks Telescoping Accessories
• 00889989087666 - Herbst Mini-Scope Accessories: 2023-04-13 Herbst Mini-Scope Accessories
• 10889989087670 - Herbst Pistons, Pk/2: 2023-04-13 Herbst Pistons, Pk/2
• 10889989087687 - Herbst Sleeves, set: 2023-04-13 Herbst Sleeves, set
• 10889989087694 - 5.5mm Hex Screw, Pk/10: 2023-04-13 5.5mm Hex Screw, Pk/10