FDA 510(k) Application Details - K070228

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K070228
Device Name Abutment, Implant, Dental, Endosseous
Applicant DENTIUM CO., LTD.
5536 TROWBRIDGE DR
ATLANTA, GA 30338 US
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Contact CATHRYN N CAMBRIA
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 01/24/2007
Decision Date 11/20/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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