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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 K102776
Device Name EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM
Applicant
Deltamed GmbH
Raiffeisenstr. 8a
Friedberg,  DE D-61169
Applicant Contact EMANUEL MESARIC
Correspondent
Deltamed GmbH
Raiffeisenstr. 8a
Friedberg,  DE D-61169
Correspondent Contact EMANUEL MESARIC
Regulation Number872.3770
Classification Product Code
EBG  
Date Received09/24/2010
Decision Date 02/18/2011
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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