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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 K122582
Device Name DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)
Applicant
DENTERPRISE INTERNATIONAL, INC.
110 east granada blvd
ormond beach,  FL  32176
Contact claude berthoin
Regulation Number872.1800
Classification Product Code
EHD  
Date Received08/23/2012
Decision Date 12/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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