FDA 510(k) Application Details - K121117

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K121117
Device Name Abutment, Implant, Dental, Endosseous
Applicant NATIONAL DENTEX CORP
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO, CA 92130 US
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Contact LINDA K SCHULZ
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 04/12/2012
Decision Date 12/14/2012
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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