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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implant, endosseous, root-form
510(k) Number K130787
Device Name QUANTUM DENTAL IMPLANT SYSTEM
Applicant
QUANTUM BIOENGINEERING, LTD.
12264 El Camino Real, Suite 400
san diego,  CA  92130
Applicant Contact linda schulz
Correspondent
QUANTUM BIOENGINEERING, LTD.
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact linda schulz
Regulation Number872.3640
Classification Product Code
DZE  
Date Received03/21/2013
Decision Date 06/13/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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