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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 K042703
Device Name CYBIRD LED CURING LIGHT
Applicant
Dxm Co., Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received09/30/2004
Decision Date 10/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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