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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K182206
Device Name RiX70 DC
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
EHD  
Date Received08/15/2018
Decision Date 09/13/2018
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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