Progressive Orthodontics App

GUDID D16409625

The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment.

PROGRESSIVE AMERICA, INC.

CAD/CAM software

• Primary Device ID: D16409625
• NIH Device Record Key: 97adc2b3-455b-4baf-90f4-c31b4274ab8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Progressive Orthodontics App
• Version Model Number: 0.9.6
• Company DUNS: 101502693
• Company Name: PROGRESSIVE AMERICA, INC.
• 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: false
• 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	D16409625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241153

FDA Product Code

• PNN: Orthodontic Software

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: 2024-11-15
• Device Publish Date: 2024-11-07