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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
Applicant Contact claude berthoin
Correspondent
DENTERPRISE INTERNATIONAL, INC.
110 east granada blvd
ormond beach,  FL  32176
Correspondent Contact claude berthoin
Regulation Number872.1800
Classification Product Code
EHD  
Date Received08/23/2012
Decision Date 12/07/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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