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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K031326
Device Name IMAGINE REFLEX
Applicant
Wieland Dental + Technik GmbH & Co. KG
Schwenninger Strasse 13
Pforzheim,  DE D75179
Applicant Contact GERHARD POLZER
Correspondent
Wieland Dental + Technik GmbH & Co. KG
Schwenninger Strasse 13
Pforzheim,  DE D75179
Correspondent Contact GERHARD POLZER
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/25/2003
Decision Date 06/17/2003
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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