ProVectra 3D Prime with VistaSoft
K-Number: K181432 · 2018-08-02
ApplicantDurr Dental SE
Decision Date2018-08-02
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ProVectra 3D Prime with VistaSoft is a medical device manufactured by Durr Dental SE. It received FDA 510(k) clearance on 2018-08-02 under approval number K181432. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ProVectra 3D Prime with VistaSoft?
ProVectra 3D Prime with VistaSoft is a medical device that received FDA 510(k) clearance on 2018-08-02. It is manufactured by Durr Dental SE. The 510(k) number is K181432.
When was ProVectra 3D Prime with VistaSoft approved by the FDA?
ProVectra 3D Prime with VistaSoft received FDA 510(k) clearance on 2018-08-02, under approval number K181432.
What company makes ProVectra 3D Prime with VistaSoft?
ProVectra 3D Prime with VistaSoft is manufactured by Durr Dental SE.
What is the FDA product code for ProVectra 3D Prime with VistaSoft?
The FDA product code for ProVectra 3D Prime with VistaSoft is OAS.
Other Devices by Durr Dental SE
Related Devices (Code: OAS)
K161900HYPERION X5Cefla S.C.
K160166X-MIND triumDe Gotzen S.R.L.
K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International
K160882PaX-i3D Green Premium (Model: PCT-90LH)VATECH Co., Ltd.
K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd.
K161881PreXion3D ExcelsiorPrexion Corporation
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.