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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retainer, Screw Expansion, Orthodontic
510(k) Number K925088
Device Name EXPANSION SCREWS
Applicant
Forestadent
7530 Pforzheim Westliche 151
Postfach 660
Germany,  DE
Applicant Contact BERNHARD FORSTER
Correspondent
Forestadent
7530 Pforzheim Westliche 151
Postfach 660
Germany,  DE
Correspondent Contact BERNHARD FORSTER
Regulation Number872.5410
Classification Product Code
DYJ  
Date Received10/07/1992
Decision Date 05/22/1993
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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