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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
Predetermined Change
Control Plan Authorized		 No
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