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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 K231202
Device Name QuickRayPRO
Applicant
Denterprise International, Inc.
156 E. Granada Blvd.
Ormond Beach,  FL  32176
Applicant Contact Claude Berthoin
Correspondent
510K FDA, Inc.
156 E. Granada Blvd.
Ormond Beach,  FL  32176
Correspondent Contact W. Lee Strong
Regulation Number872.1800
Classification Product Code
MUH  
Date Received04/27/2023
Decision Date 06/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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