FDA.reportPublic FDA data

Progressive Orthodontics App

Primary DI
D16409625
Brand
Progressive Orthodontics App
Company
PROGRESSIVE AMERICA, INC.
Model
0.9.6
Device description
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software isfor 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 treatmentplans and simulations for each individual patient and decide on the most appropriate treatment.
Published
2024-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
PNNOrthodontic Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
PNNOrthodontic SoftwareDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241153000Progressive Orthodontics AppProgressive Aligners, Inc.2024-10-11PNN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D16409625PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101502693
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D16420251Progressive Orthodontics App2.02025-04-30

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Primary DI, Brand, Company table
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