Progressive Orthodontics App

FDA UDI

Class II (US FDA UDI)

by Progressive America, Inc.

Identity

Trade Name: Progressive Orthodontics App FDA UDI
Generic Name: CAD/CAM software FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 2.0 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: D16420251 FDA UDI
510(k) Number: K241153 FDA UDI
FDA Product Code: PNN FDA UDI
LLZ FDA UDI
GMDN Term: CAD/CAM software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5470 FDA UDI
892.2050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: CAD/CAM software

Progressive Orthodontics App by Progressive America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as CAD/CAM software.

CEREC — Sirona Dental Systems GmbH · Class II
DTX Studio™ Lab — Nobel Biocare AG · Class II
SurgiCase Planner — Materialise NV · Class II
CAD/CAM Software — Sirona Dental Systems GmbH · Class II
CEREC Guide — Sirona Dental Systems GmbH · Class I
Mimics — Materialise NV · Class II
ProPlan CMF — Materialise NV · Class I
CEREC Guide — Sirona Dental Systems GmbH · Class I

Cleared under the same submission

K241153 also covers:

Progressive Orthodontics App — PROGRESSIVE AMERICA, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Progressive America, Inc.

Sources (1)

FDA UDI 03ef36ed-394f-459b-9e4d-de58319cc18c 34 fields · synced May 30, 2026