FDA 510(k) Application Details - K070935

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K070935
Device Name Implant, Endosseous, Root-Form
Applicant SUDIMPLANT SA
24 IMPASSE RENE COUZINET
PARC DE LA PLAINE
TOULOUSE 31500 FR
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Contact DIDIER SAILHAN
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 04/03/2007
Decision Date 11/09/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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