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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, endosseous, orthodontic
510(k) Number K110275
Device Name ORTHO EASY PIN
Applicant
FORESTADENT BERNHARD FORSTER GMBH
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Applicant Contact TANYA O'BRIEN
Correspondent
FORESTADENT BERNHARD FORSTER GMBH
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Correspondent Contact TANYA O'BRIEN
Regulation Number872.3640
Classification Product Code
OAT  
Date Received01/31/2011
Decision Date 06/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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