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FDA 510(k)

I-View Gold and Imagen Gold Dental Sensors

K-Number: K200625 · 2020-04-15

ApplicantTrident S.R.L
Decision Date2020-04-15
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

I-View Gold and Imagen Gold Dental Sensors is a medical device manufactured by Trident S.R.L. It received FDA 510(k) clearance on 2020-04-15 under approval number K200625. 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 I-View Gold and Imagen Gold Dental Sensors?

I-View Gold and Imagen Gold Dental Sensors is a medical device that received FDA 510(k) clearance on 2020-04-15. It is manufactured by Trident S.R.L. The 510(k) number is K200625.

When was I-View Gold and Imagen Gold Dental Sensors approved by the FDA?

I-View Gold and Imagen Gold Dental Sensors received FDA 510(k) clearance on 2020-04-15, under approval number K200625.

What company makes I-View Gold and Imagen Gold Dental Sensors?

I-View Gold and Imagen Gold Dental Sensors is manufactured by Trident S.R.L.

What is the FDA product code for I-View Gold and Imagen Gold Dental Sensors?

The FDA product code for I-View Gold and Imagen Gold Dental Sensors is MUH.

Related Clinical Trials

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Other Devices by Trident S.R.L

K162619I View and Imagen Sensor K160386ReadeR, VieweR, QuickScan PSP K182206RiX70 DC K222666X-View 3D Pan/X-View 2D Pan

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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