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 a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2017-01-31 under approval 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. It is manufactured by Nobel Biocare AB. The 510(k) number is K163122.
When was NobelClinician, DTX Studio implant approved by the FDA?
NobelClinician, DTX Studio implant received FDA 510(k) clearance on 2017-01-31, under approval number K163122.
What company makes NobelClinician, DTX Studio implant?
NobelClinician, DTX Studio implant is manufactured by Nobel Biocare AB.
What is the FDA product code for NobelClinician, DTX Studio implant?
The FDA product code for NobelClinician, DTX Studio implant is LLZ.
Other Devices by Nobel Biocare AB
Related Devices (Code: LLZ)
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.