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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002 Xpandortho Inc. Rebecca Pine Official Correspondent 2223 Avenida De La Playa Suite 203 La Jolla California 92037-3218 April 25 2017 Re K162237...
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Who needs xpandortho?

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Orthodontists: XpandOrtho is primarily designed for orthodontists who need an efficient tool to manage their patient records, treatment plans, and communication.
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Orthodontic Patients: While not directly using XpandOrtho, orthodontic patients indirectly benefit from this software as it helps in improving treatment planning, accuracy, and overall orthodontic care.
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xpandortho is a software designed for orthodontic practices to manage patient information, treatment plans, scheduling, and billing.
Orthodontic practices that use xpandortho software are required to file patient information, treatment plans, and billing through the system.
To fill out xpandortho, orthodontic staff must input patient demographics, treatment details, appointment schedules, and billing information into the software.
The purpose of xpandortho is to streamline and organize the workflow of orthodontic practices by centralizing patient information and treatment plans.
Information such as patient demographics, treatment plans, progress notes, appointment schedules, and billing details must be reported on xpandortho.
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