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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 K070007
Device Name SPI ELEMENT PLATFORM O 4.0 MM
Applicant
THOMMEN MEDICAL, AG
11234 EL CAMINO REAL, STE. 200
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
THOMMEN MEDICAL, AG
11234 EL CAMINO REAL, STE. 200
san diego,  CA  92130
Correspondent Contact floyd g larson
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/03/2007
Decision Date 01/10/2007
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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