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FDA 510(k)

coDiagnostiX

K-Number: K193301 · 2021-06-21

ApplicantDental Wings GmbH
Decision Date2021-06-21
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

coDiagnostiX is a medical device manufactured by Dental Wings GmbH. It received FDA 510(k) clearance on 2021-06-21 under approval number K193301. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the coDiagnostiX?

coDiagnostiX is a medical device that received FDA 510(k) clearance on 2021-06-21. It is manufactured by Dental Wings GmbH. The 510(k) number is K193301.

When was coDiagnostiX approved by the FDA?

coDiagnostiX received FDA 510(k) clearance on 2021-06-21, under approval number K193301.

What company makes coDiagnostiX?

coDiagnostiX is manufactured by Dental Wings GmbH.

What is the FDA product code for coDiagnostiX?

The FDA product code for coDiagnostiX is DZJ.

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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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