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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
Other 510(k) Applications for this Contact
Regulation Number
872.3640
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Classification Product Code
DZE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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