FDA 510(k) Application Details - K022258

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K022258
Device Name Implant, Endosseous, Root-Form
Applicant B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.
PARQUE TECNOLOGICO DE ALAVA
LEONARDO DA VINCI, 14B
01510 MINANO (ALAVA) ES
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Contact ALFREDOCO GOMEZ
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 07/12/2002
Decision Date 09/11/2003
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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