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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K200625
Device Name I-View Gold and Imagen Gold Dental Sensors
Applicant
Trident S.R.L
Via Artigiani 4
Castenedolo,  IT 25014
Applicant Contact Giorgio Rizzo
Correspondent
The 510k Consulting, LLC
1449 Springleaf Dr.
Ormond Beach,  FL  32174
Correspondent Contact Joyce St. Germain
Regulation Number872.1800
Classification Product Code
MUH  
Date Received03/10/2020
Decision Date 04/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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