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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Durr Dental SE. It received FDA 510(k) clearance on 2020-03-05 under 510(k) 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. The listed applicant is Durr Dental SE. The 510(k) number is K193139.

When did ProVecta 3D Prime Ceph receive FDA 510(k) clearance?

ProVecta 3D Prime Ceph received FDA 510(k) clearance on 2020-03-05, under 510(k) number K193139.

Who is the listed applicant for ProVecta 3D Prime Ceph?

The FDA 510(k) record lists Durr Dental SE as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProVecta 3D Prime Ceph?

The FDA product code for ProVecta 3D Prime Ceph is OAS.

Other records listing Durr Dental SE as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250947VistaSoft 4.0 and VisionX 4.0K232487Provecta 3D Prime and Provecta 3D Prime CephK230095ScanX Swift 2.0, ScanX Swift View 2.0K213326VisionX 3.0K203116SensorXK192743VisionX 2.4

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Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

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.

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