FDA 510(k) Application Details - K974280

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K974280
Device Name Implant, Endosseous, Root-Form
Applicant THE IMPLANT CENTER OF THE PALM BEACHES
824 US HWY I, STE. 370
N. PALM BEACH, FL 33408 US
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Contact JACK T KRAUSER
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 11/05/1997
Decision Date 02/20/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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