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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 K992909
Device Name HYTAC
Applicant
Espe Dental AG
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Applicant Contact ANDREAS PETERMAN
Correspondent
Espe Dental AG
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Correspondent Contact ANDREAS PETERMAN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received08/30/1999
Decision Date 11/24/1999
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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