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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 K051502
Device Name SPI DENTAL IMPLANT
Applicant
THOMMEN MEDICAL, AG
11234 EL CAMINO REAL, STE. 200
SAN DIEGO,  CA  92130
Applicant Contact Floyd Larson
Correspondent
THOMMEN MEDICAL, AG
11234 EL CAMINO REAL, STE. 200
SAN DIEGO,  CA  92130
Correspondent Contact Floyd Larson
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/07/2005
Decision Date 06/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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