FDA 510(k) Application Details - K052823

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K052823
Device Name Abutment, Implant, Dental, Endosseous
Applicant DENTIUM, INC.
28711 JAEGER DRIVE
LAGUNA NIGUEL, CA 92677 US
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Contact KLAAS BESSELING
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 10/04/2005
Decision Date 02/21/2006
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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