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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 K023645
Device Name SPI EASY DENTAL IMPLANT ABUTMENT
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 Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
DZE  
Date Received10/30/2002
Decision Date 11/13/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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