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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 the device name listed in this FDA 510(k) record. The listed applicant is Trident S.R.L. It received FDA 510(k) clearance on 2020-04-15 under 510(k) 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. The listed applicant is Trident S.R.L. The 510(k) number is K200625.

When did I-View Gold and Imagen Gold Dental Sensors receive FDA 510(k) clearance?

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

Who is the listed applicant for I-View Gold and Imagen Gold Dental Sensors?

The FDA 510(k) record lists Trident S.R.L as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Trident S.R.L 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.

K222666X-View 3D Pan/X-View 2D PanK182206RiX70 DCK162619I View and Imagen SensorK160386ReadeR, VieweR, QuickScan PSP

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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