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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 K973513
Device Name SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER
Applicant
Espe GmbH & Co. Kg.
Am Griesberg 2
Seefeld,  DE D-82229
Applicant Contact BARBARA WAGNER-SCHUH
Correspondent
Espe GmbH & Co. Kg.
Am Griesberg 2
Seefeld,  DE D-82229
Correspondent Contact BARBARA WAGNER-SCHUH
Regulation Number872.3690
Classification Product Code
EBF  
Date Received09/17/1997
Decision Date 12/22/1997
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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