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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 K962440
Device Name PERTAC II/PERTAC II APLITIP
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 Number872.3690
Classification Product Code
EBF  
Date Received06/24/1996
Decision Date 09/11/1996
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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