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FDA 510(k)

NobelClinician, DTX Studio implant

K-Number: K163122 · 2017-01-31

ApplicantNobel Biocare AB
Decision Date2017-01-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NobelClinician, DTX Studio implant 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 2017-01-31 under 510(k) number K163122. 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 NobelClinician, DTX Studio implant?

NobelClinician, DTX Studio implant is a medical device that received FDA 510(k) clearance on 2017-01-31. The listed applicant is Nobel Biocare AB. The 510(k) number is K163122.

When did NobelClinician, DTX Studio implant receive FDA 510(k) clearance?

NobelClinician, DTX Studio implant received FDA 510(k) clearance on 2017-01-31, under 510(k) number K163122.

Who is the listed applicant for NobelClinician, DTX Studio implant?

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 NobelClinician, DTX Studio implant?

The FDA product code for NobelClinician, DTX Studio implant 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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