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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 K112279
Device Name QUANTUM DENTAL IMPLANT SYSTEM
Applicant
QUANTUM BIOENGINEERING, LTD.
11234 EL CAMINO REAL,
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact LINDA SCHULZ
Correspondent
QUANTUM BIOENGINEERING, LTD.
11234 EL CAMINO REAL,
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact LINDA SCHULZ
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received08/09/2011
Decision Date 05/04/2012
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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