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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 the device name listed in this FDA 510(k) record. The listed applicant is Durr Dental SE. It received FDA 510(k) clearance on 2021-03-19 under 510(k) 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. The listed applicant is Durr Dental SE. The 510(k) number is K203116.

When did SensorX receive FDA 510(k) clearance?

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

Who is the listed applicant for SensorX?

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 SensorX?

The FDA product code for SensorX is MUH.

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.

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Related Devices (Code: MUH)

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.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, 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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