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 a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2019-03-01 under approval 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. It is manufactured by Nobel Biocare AB. The 510(k) number is K181932.
When was DTX Studio design approved by the FDA?
DTX Studio design received FDA 510(k) clearance on 2019-03-01, under approval number K181932.
What company makes DTX Studio design?
DTX Studio design is manufactured by Nobel Biocare AB.
What is the FDA product code for DTX Studio design?
The FDA product code for DTX Studio design is PNP.
Other Devices by Nobel Biocare AB
Related Devices (Code: PNP)
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.