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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Headgear, Extraoral, Orthodontic
510(k) Number K925240
Device Name FACEBOW
Applicant
Forestadent Bernhard Forster GmbH
7530 Pforzheim
Westliche 151 Postfach 660
D-7530 Pforzheim Germany,  GR
Correspondent
Forestadent Bernhard Forster GmbH
7530 Pforzheim
Westliche 151 Postfach 660
D-7530 Pforzheim Germany,  GR
Regulation Number872.5500
Classification Product Code
DZB  
Date Received10/16/1992
Decision Date 06/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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