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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
Bavaria D-82228 Seefeld,  DE D-82229
Applicant Contact ANDREAS PETERMANN
Correspondent
Espe Dental AG
Espe Platz
Bavaria D-82228 Seefeld,  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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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