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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K102804
Device Name SPI TITANIUM BASE FOR CAD/CAM
Applicant
THOMMEN MEDICAL, AG
11234 EL CAMINO REAL,
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact LINDA K SCHULZ
Correspondent
THOMMEN MEDICAL, AG
11234 EL CAMINO REAL,
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact LINDA K SCHULZ
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/27/2010
Decision Date 04/20/2011
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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