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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
Predetermined Change
Control Plan Authorized		 No
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