FDA 510(k) Application Details - K102436

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K102436
Device Name Implant, Endosseous, Root-Form
Applicant NOBEL BIOCARE AB
15 BOHUSGATAN,
P.O. BOX 5190
GOTEBORG S-402 26 SE
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Contact HERBERT CRANE
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 08/26/2010
Decision Date 12/09/2010
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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