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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 K960547
Device Name DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE
Applicant
Espe GmbH & Co. Kg.
Am Griesberg 2
Seefeld,  DE D-82229
Applicant Contact BARBARA WAGNER
Correspondent
Espe GmbH & Co. Kg.
Am Griesberg 2
Seefeld,  DE D-82229
Correspondent Contact BARBARA WAGNER
Regulation Number872.3660
Classification Product Code
ELW  
Date Received02/08/1996
Decision Date 03/15/1996
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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