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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 K052061
Device Name MODUS IMF SCREWS 2.0
Applicant
MEDARTIS, INC.
11234 EL CAMINO REAL, STE 200
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
MEDARTIS, INC.
11234 EL CAMINO REAL, STE 200
san diego,  CA  92130
Correspondent Contact floyd g larson
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/29/2005
Decision Date 10/21/2005
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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