FDA 510(k) Application Details - K050258

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K050258
Device Name Implant, Endosseous, Root-Form
Applicant NOBEL BIOCARE AB
22715 SAVI RANCH PKWY.
YORBA LINDA, CA 92887 US
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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 02/03/2005
Decision Date 04/19/2005
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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