FDA 510(k) Application Details - K062749

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K062749
Device Name Abutment, Implant, Dental, Endosseous
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 872.3630

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Classification Product Code NHA
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Date Received 09/14/2006
Decision Date 11/29/2006
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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