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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 K012299
Device Name MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM
Applicant
Basic Dental Implant Systems, Inc.
3321 Columbia NE
Albuquerque,  NM  87107 -2001
Applicant Contact DAN BLACKLOCK
Correspondent
Basic Dental Implant Systems, Inc.
3321 Columbia NE
Albuquerque,  NM  87107 -2001
Correspondent Contact DAN BLACKLOCK
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/20/2001
Decision Date 08/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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