Cleared Traditional

TP Orthodontics Clear Aligner System

K193385 · Tp Orthodontics, Inc. · Dental
Nov 2020
Decision
342d
Days
Class 2
Risk

About This 510(k) Submission

K193385 is an FDA 510(k) clearance for the TP Orthodontics Clear Aligner System, a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by Tp Orthodontics, Inc. (La Porte, US). The FDA issued a Cleared decision on November 12, 2020, 342 days after receiving the submission on December 6, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K193385 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2019
Decision Date November 12, 2020
Days to Decision 342 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NXC — Aligner, Sequential
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.