FDA 510(k) Application Details - K070533

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K070533
Device Name Abutment, Implant, Dental, Endosseous
Applicant B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.
LEONARDO DA VINCI, 14 B
MINANO MENOR, ALAVA 01510 ES
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Contact ;EYRE Z HERNANDO
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 02/26/2007
Decision Date 06/21/2007
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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