Clearguide Express

GUDID 00889989061987

Set of clear plastic aligners – corrects minor to intermediate anterior malalignments of teeth

ALLESEE AOA-PRO

Orthodontic progressive aligner

• Primary Device ID: 00889989061987
• NIH Device Record Key: be82e3d7-cd86-47dd-a527-c1a1f7c20c41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clearguide Express
• Version Model Number: 3000-0006
• Company DUNS: 158312728
• Company Name: ALLESEE AOA-PRO
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 262-886-1050
• Email: xxx@xxx.xxx
• Phone: 262-886-1050
• Email: xxx@xxx.xxx
• Phone: 262-886-1050
• Email: xxx@xxx.xxx
• Phone: 262-886-1050
• Email: xxx@xxx.xxx
• Phone: 262-886-1050
• Email: xxx@xxx.xxx
• Phone: 262-886-1050
• Email: xxx@xxx.xxx
• Phone: 262-886-1050
• Email: xxx@xxx.xxx
• Phone: 262-886-1050
• Email: xxx@xxx.xxx
• Phone: 262-886-1050
• Email: xxx@xxx.xxx
• Phone: 262-886-1050
• Email: xxx@xxx.xxx
• Phone: 262-886-1050
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889989061987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093821

FDA Product Code

• NXC: Aligner, Sequential

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2016-09-08

Devices Manufactured by ALLESEE AOA-PRO

• 00889989088571 - Prezurv Plus: 2024-05-13 Prezurv Plus
• 00889989081817 - Memotain: 2023-08-01 Memotain
• 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