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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 K962106
Device Name SPLINE DENTAL IMPLANT SYSTEMS
Applicant
Calcitek, Inc.
2320 Faraday Ave.
Carlsbad,  CA  92008
Applicant Contact DONNA K HOWARD
Correspondent
Calcitek, Inc.
2320 Faraday Ave.
Carlsbad,  CA  92008
Correspondent Contact DONNA K HOWARD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/31/1996
Decision Date 08/29/1996
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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