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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name crown and bridge, temporary, resin
510(k) Number K120779
Device Name STRUCTUR 3
Original Applicant
anton-flettner-strasse 1-3
cuxhaven,  DE d-27472
Original Contact t. gerkensmeier
Regulation Number872.3770
Classification Product Code
Date Received03/14/2012
Decision Date 06/01/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No