Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TP Orthodontics Clear Aligner System

K-Number: K193385 · 2020-11-12

ApplicantTp Orthodontics, Inc.
Decision Date2020-11-12
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TP Orthodontics Clear Aligner System is a medical device manufactured by Tp Orthodontics, Inc.. It received FDA 510(k) clearance on 2020-11-12 under approval number K193385. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TP Orthodontics Clear Aligner System?

TP Orthodontics Clear Aligner System is a medical device that received FDA 510(k) clearance on 2020-11-12. It is manufactured by Tp Orthodontics, Inc.. The 510(k) number is K193385.

When was TP Orthodontics Clear Aligner System approved by the FDA?

TP Orthodontics Clear Aligner System received FDA 510(k) clearance on 2020-11-12, under approval number K193385.

What company makes TP Orthodontics Clear Aligner System?

TP Orthodontics Clear Aligner System is manufactured by Tp Orthodontics, Inc..

What is the FDA product code for TP Orthodontics Clear Aligner System?

The FDA product code for TP Orthodontics Clear Aligner System is NXC.

Related Clinical Trials

NCT07610603 Cleaning Methods for Clear Aligners COMPLETED NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT04786821 Acceptability of Exoskeleton Assisted Walking for Persons With Mobility Issues Due to Multiple Sclerosis COMPLETED NCT07193407 INOPASE - Performance and Safety Study of a Personalised SNM System RECRUITING NCT07591025 Comparison Between Mandibular Advancement With Aligners and Twin Block in Class II Malocclusion in Growing Patients COMPLETED

Other Devices by Tp Orthodontics, Inc.

K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520

Related Devices (Code: NXC)

K151965Dentti SystemMartz, Inc. K162609ClearPath AlignerClearpath Orthodontics, Ltd. K163155MTM Clear AlignerDentsply Sirona K1636893M Clear Tray Aligner3M Unitek Corporation K1831593M Clarity Aligners3M Company K182329SureCure Orthodontic Aligner SystemDigital Orthodontic Care

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑