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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
Applicant
KTK MEDICAL SUPPLIES GMBH
INDUSTRIESTR. 16
GERMERING,  DE D-821110
Applicant Contact THOMAS LOTTERMOSER
Correspondent
KTK MEDICAL SUPPLIES GMBH
INDUSTRIESTR. 16
GERMERING,  DE D-821110
Correspondent 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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