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FDA 510(k)

DTX Studio diagnose

K-Number: K172224 · 2018-01-11

ApplicantNobel Biocare AB
Decision Date2018-01-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DTX Studio diagnose is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2018-01-11 under 510(k) 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. The listed applicant is Nobel Biocare AB. The 510(k) number is K172224.

When did DTX Studio diagnose receive FDA 510(k) clearance?

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

Who is the listed applicant for DTX Studio diagnose?

The FDA 510(k) record lists Nobel Biocare AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DTX Studio diagnose?

The FDA product code for DTX Studio diagnose is LLZ.

Other records listing Nobel Biocare AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LLZ)

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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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