FDA 510(k) Application Details - K070601

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K070601
Device Name Implant, Endosseous, Root-Form
Applicant INTRA-LOCK INTERNATIONAL
1200 NORTH FEDERAL HWY.
SUITE 209
BOCA RATON, FL 33432 US
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Contact JEFFREY SAKOFF
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 03/02/2007
Decision Date 10/12/2007
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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