AccessGUDID - DEVICE: Progressive Orthodontics App (D16409625)

GUDID

Device Identifier (DI) Information

Brand Name: Progressive Orthodontics App
Version or Model: 0.9.6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PROGRESSIVE AMERICA, INC.

Primary DI Number: D16409625
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101502693 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
50484	CAD/CAM software	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PNN	Orthodontic Software
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241153	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 97adc2b3-455b-4baf-90f4-c31b4274ab8d
Public Version Date: November 15, 2024
Public Version Number: 1
DI Record Publish Date: November 07, 2024