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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, impression
510(k) Number K000591
Device Name DIMENSION PENTA H, DIMENSION PENTA H 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 Number872.3660
Classification Product Code
ELW  
Date Received02/22/2000
Decision Date 03/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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