FDA 510(k) Application Details - K141457

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K141457
Device Name Abutment, Implant, Dental, Endosseous
Applicant DENTIUM CO. LTD.
6761 KATELLA AVE.
CYPRESS, CA 90630 US
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Contact SHERYL HIGGINS
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 06/02/2014
Decision Date 11/12/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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