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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 the device name listed in this FDA 510(k) record. The listed applicant is Tp Orthodontics, Inc.. It received FDA 510(k) clearance on 2020-11-12 under 510(k) 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. The listed applicant is Tp Orthodontics, Inc.. The 510(k) number is K193385.

When did TP Orthodontics Clear Aligner System receive FDA 510(k) clearance?

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

Who is the listed applicant for TP Orthodontics Clear Aligner System?

The FDA 510(k) record lists Tp Orthodontics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07638397Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner SystemNOT_YET_RECRUITINGNCT07687329Direct vs Indirect In-House Clear Aligners vs Fixed Appliances in Orthodontic TreatmentCOMPLETED

Other records listing Tp Orthodontics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: NXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

Official Source

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

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