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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 K001259
Device Name 2-PIECE POST AND CORE FOR THE B.A.S.I.C. 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 Received04/19/2000
Decision Date 01/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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