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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Implant, Dental, Endosseous
510(k) Number K070290
Device Name SPI VECTODRILL CERAMIC DRILLS
Applicant
Thommen Medical AG
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact Floyd Larson
Correspondent
Thommen Medical AG
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact Floyd Larson
Regulation Number872.3980
Classification Product Code
NDP  
Date Received01/30/2007
Decision Date 04/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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