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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, Intraoral
510(k) Number K080738
Device Name DENTRON SENSOR
Applicant
Dentron Systems, LLC
11 E. Granada Blvd.
Suite 207
Ormond Beach,  FL  32176
Applicant Contact CLAUDE D BERTHOIN
Correspondent
Dentron Systems, LLC
11 E. Granada Blvd.
Suite 207
Ormond Beach,  FL  32176
Correspondent Contact CLAUDE D BERTHOIN
Regulation Number872.1810
Classification Product Code
EAP  
Subsequent Product Code
MQB  
Date Received03/17/2008
Decision Date 05/13/2008
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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