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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name crown and bridge, temporary, resin
510(k) Number K122025
Device Name BRIGHTGLASS BRIGHTGLASS M
Original Applicant
KTK MEDICAL SUPPLIES GMBH
industriestr. 16
germering,  DE d-821110
Original Contact thomas lottermoser
Regulation Number872.3770
Classification Product Code
EBG  
Date Received07/11/2012
Decision Date 10/09/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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