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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 K962576
Device Name SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM
Applicant
Calcitek, Inc.
2320 Faraday Ave.
Carlsbad,  CA  92008 -7216
Applicant Contact DONNA K HOWARD
Correspondent
Calcitek, Inc.
2320 Faraday Ave.
Carlsbad,  CA  92008 -7216
Correspondent Contact DONNA K HOWARD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/01/1996
Decision Date 02/10/1997
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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