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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 K011879
Device Name 3A DENTAL IMPLANT SYSTEM
Applicant
Osseco Biosource, Ltd.
P.O.Box 848
Grayslake,  IL  60030
Applicant Contact MICHELE H VOVOLKA
Correspondent
Osseco Biosource, Ltd.
P.O.Box 848
Grayslake,  IL  60030
Correspondent Contact MICHELE H VOVOLKA
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/15/2001
Decision Date 08/27/2002
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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