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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
Models A1-A2, A1-A3, A1-A3,5, A2-A3, 5, B1,A,B,C,A4,B4
Device Name BRIGHTGLASS BRIGHTGLASS M
Original Applicant
KTK MEDICAL SUPPLIES GMBH
industriestr. 16
germering,  GM 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 (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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