DTX Studio Clinic 3.0
K-Number: K213562 · 2022-03-25
ApplicantNobel Biocare AB
Decision Date2022-03-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DTX Studio Clinic 3.0 is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2022-03-25 under approval number K213562. 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 DTX Studio Clinic 3.0?
DTX Studio Clinic 3.0 is a medical device that received FDA 510(k) clearance on 2022-03-25. It is manufactured by Nobel Biocare AB. The 510(k) number is K213562.
When was DTX Studio Clinic 3.0 approved by the FDA?
DTX Studio Clinic 3.0 received FDA 510(k) clearance on 2022-03-25, under approval number K213562.
What company makes DTX Studio Clinic 3.0?
DTX Studio Clinic 3.0 is manufactured by Nobel Biocare AB.
What is the FDA product code for DTX Studio Clinic 3.0?
The FDA product code for DTX Studio Clinic 3.0 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.