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FDA 510(k)

SensorX

K-Number: K203116 · 2021-03-19

ApplicantDurr Dental SE
Decision Date2021-03-19
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SensorX is a medical device manufactured by Durr Dental SE. It received FDA 510(k) clearance on 2021-03-19 under approval number K203116. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SensorX?

SensorX is a medical device that received FDA 510(k) clearance on 2021-03-19. It is manufactured by Durr Dental SE. The 510(k) number is K203116.

When was SensorX approved by the FDA?

SensorX received FDA 510(k) clearance on 2021-03-19, under approval number K203116.

What company makes SensorX?

SensorX is manufactured by Durr Dental SE.

What is the FDA product code for SensorX?

The FDA product code for SensorX is MUH.

Other Devices by Durr Dental SE

K181432ProVectra 3D Prime with VistaSoft K192743VisionX 2.4 K190629DBSWIN and VISTAEASY Imaging Software K193139ProVecta 3D Prime Ceph K213326VisionX 3.0 K232487Provecta 3D Prime and Provecta 3D Prime Ceph

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Related Devices (Code: MUH)

K162619I View and Imagen SensorTrident S.R.L K162585SuniIQ Digital Radiography SystemSuni Medical Imaging, Inc. K161131FONA Pan/CephFona S.R.L K160788RIOScan (RPS500)Ray Co., Ltd. K160386ReadeR, VieweR, QuickScan PSPTrident S.R.L K153144TIO-H DIGITAL RADIOGRAPHY SENSORDenttio, Inc.

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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