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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K070373
Device Name APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
Applicant
APOZA ENTERPRISE CO. LTD.
2904 N. BOLDT DR.
FLAGSTAFF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
APOZA ENTERPRISE CO. LTD.
2904 N. BOLDT DR.
FLAGSTAFF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received02/08/2007
Decision Date 03/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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