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FDA 510(k)

SmileAlign Orthodontic Aligner System

K-Number: K191774 · 2019-09-30

Applicant3D Global Biotech, Inc.
Decision Date2019-09-30
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SmileAlign Orthodontic Aligner System is a medical device manufactured by 3D Global Biotech, Inc.. It received FDA 510(k) clearance on 2019-09-30 under approval number K191774. 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 SmileAlign Orthodontic Aligner System?

SmileAlign Orthodontic Aligner System is a medical device that received FDA 510(k) clearance on 2019-09-30. It is manufactured by 3D Global Biotech, Inc.. The 510(k) number is K191774.

When was SmileAlign Orthodontic Aligner System approved by the FDA?

SmileAlign Orthodontic Aligner System received FDA 510(k) clearance on 2019-09-30, under approval number K191774.

What company makes SmileAlign Orthodontic Aligner System?

SmileAlign Orthodontic Aligner System is manufactured by 3D Global Biotech, Inc..

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

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

Related Clinical Trials

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Other Devices by 3D Global Biotech, Inc.

K212803DailyMate Orthodontic Aligner System

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.

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