FDA 510(k) Application Details - K052997

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K052997
Device Name Implant, Endosseous, Root-Form
Applicant ZIMMER DENTAL INC.
1900 ASTON AVE.
CARLSBAD, CA 92008-7308 US
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Contact ERIN MCVEY
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 10/25/2005
Decision Date 01/23/2006
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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