ProVecta 3D Prime Ceph
K-Number: K193139 · 2020-03-05
ApplicantDurr Dental SE
Decision Date2020-03-05
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ProVecta 3D Prime Ceph is a medical device manufactured by Durr Dental SE. It received FDA 510(k) clearance on 2020-03-05 under approval number K193139. 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 ProVecta 3D Prime Ceph?
ProVecta 3D Prime Ceph is a medical device that received FDA 510(k) clearance on 2020-03-05. It is manufactured by Durr Dental SE. The 510(k) number is K193139.
When was ProVecta 3D Prime Ceph approved by the FDA?
ProVecta 3D Prime Ceph received FDA 510(k) clearance on 2020-03-05, under approval number K193139.
What company makes ProVecta 3D Prime Ceph?
ProVecta 3D Prime Ceph is manufactured by Durr Dental SE.
What is the FDA product code for ProVecta 3D Prime Ceph?
The FDA product code for ProVecta 3D Prime Ceph 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.