Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

3D Predict

K-Number: K200214 · 2020-02-24

Applicant3D Smile USA, Inc.
Decision Date2020-02-24
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3D Predict is a medical device manufactured by 3D Smile USA, Inc.. It received FDA 510(k) clearance on 2020-02-24 under approval number K200214. 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 3D Predict?

3D Predict is a medical device that received FDA 510(k) clearance on 2020-02-24. It is manufactured by 3D Smile USA, Inc.. The 510(k) number is K200214.

When was 3D Predict approved by the FDA?

3D Predict received FDA 510(k) clearance on 2020-02-24, under approval number K200214.

What company makes 3D Predict?

3D Predict is manufactured by 3D Smile USA, Inc..

What is the FDA product code for 3D Predict?

The FDA product code for 3D Predict is NXC.

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.

↑