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FDA 510(k)

DailyMate Orthodontic Aligner System

K-Number: K212803 · 2022-05-23

Applicant3D Global Biotech, Inc.
Decision Date2022-05-23
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DailyMate Orthodontic Aligner System is a medical device manufactured by 3D Global Biotech, Inc.. It received FDA 510(k) clearance on 2022-05-23 under approval number K212803. 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 DailyMate Orthodontic Aligner System?

DailyMate Orthodontic Aligner System is a medical device that received FDA 510(k) clearance on 2022-05-23. It is manufactured by 3D Global Biotech, Inc.. The 510(k) number is K212803.

When was DailyMate Orthodontic Aligner System approved by the FDA?

DailyMate Orthodontic Aligner System received FDA 510(k) clearance on 2022-05-23, under approval number K212803.

What company makes DailyMate Orthodontic Aligner System?

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

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

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

Related Clinical Trials

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Other Devices by 3D Global Biotech, Inc.

K191774SmileAlign Orthodontic Aligner System

Related Devices (Code: NXC)

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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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