VisionX 3.0
K-Number: K213326 · 2021-11-02
ApplicantDurr Dental SE
Decision Date2021-11-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
VisionX 3.0 is a medical device manufactured by Durr Dental SE. It received FDA 510(k) clearance on 2021-11-02 under approval number K213326. 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 VisionX 3.0?
VisionX 3.0 is a medical device that received FDA 510(k) clearance on 2021-11-02. It is manufactured by Durr Dental SE. The 510(k) number is K213326.
When was VisionX 3.0 approved by the FDA?
VisionX 3.0 received FDA 510(k) clearance on 2021-11-02, under approval number K213326.
What company makes VisionX 3.0?
VisionX 3.0 is manufactured by Durr Dental SE.
What is the FDA product code for VisionX 3.0?
The FDA product code for VisionX 3.0 is LLZ.
Other Devices by Durr Dental SE
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.