Cleared Traditional

Progressive Orthodontics App

K241153 · Progressive Aligners, Inc. · Dental
Oct 2024
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K241153 is an FDA 510(k) clearance for the Progressive Orthodontics App, a Orthodontic Software (Class II — Special Controls, product code PNN), submitted by Progressive Aligners, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on October 11, 2024, 168 days after receiving the submission on April 26, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K241153 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2024
Decision Date October 11, 2024
Days to Decision 168 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code PNN — Orthodontic Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only.