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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 K991221
Device Name VESTOGUM
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 Received04/12/1999
Decision Date 05/20/1999
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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