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FDA 510(k)

Orthodontic Appliance

K-Number: K181747 · 2019-04-18

ApplicantShandong Huge Dental Material Corporation
Decision Date2019-04-18
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Orthodontic Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2019-04-18 under 510(k) number K181747. 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 Orthodontic Appliance?

Orthodontic Appliance is a medical device that received FDA 510(k) clearance on 2019-04-18. The listed applicant is Shandong Huge Dental Material Corporation. The 510(k) number is K181747.

When did Orthodontic Appliance receive FDA 510(k) clearance?

Orthodontic Appliance received FDA 510(k) clearance on 2019-04-18, under 510(k) number K181747.

Who is the listed applicant for Orthodontic Appliance?

The FDA 510(k) record lists Shandong Huge Dental Material Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orthodontic Appliance?

The FDA product code for Orthodontic Appliance 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.

NCT07550179Labial White Spot Lesions and Proximal Caries Development in Orthodontic Patients Using Clear Aligners Versus Traditional Braces.COMPLETED

Other records listing Shandong Huge Dental Material Corporation as applicant

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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

View on FDA Database →

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

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