NobelDesign, DTX Studio Design
K-Number: K171466 · 2017-11-29
ApplicantNobel Biocare AB
Decision Date2017-11-29
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
NobelDesign, DTX Studio Design is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2017-11-29 under approval number K171466. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NobelDesign, DTX Studio Design?
NobelDesign, DTX Studio Design is a medical device that received FDA 510(k) clearance on 2017-11-29. It is manufactured by Nobel Biocare AB. The 510(k) number is K171466.
When was NobelDesign, DTX Studio Design approved by the FDA?
NobelDesign, DTX Studio Design received FDA 510(k) clearance on 2017-11-29, under approval number K171466.
What company makes NobelDesign, DTX Studio Design?
NobelDesign, DTX Studio Design is manufactured by Nobel Biocare AB.
What is the FDA product code for NobelDesign, DTX Studio Design?
The FDA product code for NobelDesign, DTX Studio Design is NHA.
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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.