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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 a medical device manufactured by Digital Orthodontic Care. It received FDA 510(k) clearance on 2018-11-08 under approval 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. It is manufactured by Digital Orthodontic Care. The 510(k) number is K182329.

When was SureCure Orthodontic Aligner System approved by the FDA?

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

What company makes SureCure Orthodontic Aligner System?

SureCure Orthodontic Aligner System is manufactured by Digital Orthodontic Care.

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

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

Related Clinical Trials

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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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