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FDA 510(k)

SureCure Orthodontic Aligner System

K-Number: K182329 · 2018-11-08

ApplicantDigital Orthodontic Care
Decision Date2018-11-08
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SureCure Orthodontic Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Digital Orthodontic Care. It received FDA 510(k) clearance on 2018-11-08 under 510(k) number K182329. 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 SureCure Orthodontic Aligner System?

SureCure Orthodontic Aligner System is a medical device that received FDA 510(k) clearance on 2018-11-08. The listed applicant is Digital Orthodontic Care. The 510(k) number is K182329.

When did SureCure Orthodontic Aligner System receive FDA 510(k) clearance?

SureCure Orthodontic Aligner System received FDA 510(k) clearance on 2018-11-08, under 510(k) number K182329.

Who is the listed applicant for SureCure Orthodontic Aligner System?

The FDA 510(k) record lists Digital Orthodontic Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SureCure Orthodontic Aligner System?

The FDA product code for SureCure Orthodontic Aligner System is NXC.

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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