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FDA 510(k)

DTX Studio diagnose

K-Number: K172224 · 2018-01-11

Decision Date2018-01-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DTX Studio diagnose is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2018-01-11 under approval number K172224. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DTX Studio diagnose?

DTX Studio diagnose is a medical device that received FDA 510(k) clearance on 2018-01-11. It is manufactured by Nobel Biocare AB. The 510(k) number is K172224.

When was DTX Studio diagnose approved by the FDA?

DTX Studio diagnose received FDA 510(k) clearance on 2018-01-11, under approval number K172224.

What company makes DTX Studio diagnose?

DTX Studio diagnose is manufactured by Nobel Biocare AB.

What is the FDA product code for DTX Studio diagnose?

The FDA product code for DTX Studio diagnose is LLZ.

Other Devices by Nobel Biocare AB

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Related Devices (Code: LLZ)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.