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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K994251
Device Name KETAC-MOLAR QUICK
Applicant
ESPE DENTAL AG
ESPE PLATZ
SEEFELD, BAVARIA,  DE D-82229
Applicant Contact ANDREAS PETERMANN
Correspondent
ESPE DENTAL AG
ESPE PLATZ
SEEFELD, BAVARIA,  DE D-82229
Correspondent Contact ANDREAS PETERMANN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received12/17/1999
Decision Date 01/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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