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FDA 510(k)

DTX Studio design

K-Number: K181932 · 2019-03-01

ApplicantNobel Biocare AB
Decision Date2019-03-01
Product CodePNP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DTX Studio design 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 2019-03-01 under 510(k) number K181932. The device is classified under product code PNP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DTX Studio design?

DTX Studio design is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Nobel Biocare AB. The 510(k) number is K181932.

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

DTX Studio design received FDA 510(k) clearance on 2019-03-01, under 510(k) number K181932.

Who is the listed applicant for DTX Studio design?

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 design?

The FDA product code for DTX Studio design is PNP.

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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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