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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K052073
Device Name FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000
Applicant
Schutz-Dental GmbH
Dieselstrasse 5-6
Rosbach,  DE D-61191
Applicant Contact MICHAEL WIERZ
Correspondent
Schutz-Dental GmbH
Dieselstrasse 5-6
Rosbach,  DE D-61191
Correspondent Contact MICHAEL WIERZ
Regulation Number872.3760
Classification Product Code
EBI  
Date Received08/01/2005
Decision Date 10/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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