FDA 510(k) Application Details - K110275

Device Classification Name Implant, Endosseous, Orthodontic

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510(K) Number K110275
Device Name Implant, Endosseous, Orthodontic
Applicant FORESTADENT BERNHARD FORSTER GMBH
962 ALLEGRO LANE
APOLLO BEACH, FL 33572 US
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Contact TANYA O'BRIEN
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Regulation Number 872.3640

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Classification Product Code OAT
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Date Received 01/31/2011
Decision Date 06/03/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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