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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 K946319
Device Name INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
Applicant
Calcitek, Inc.
2320 Faraday Ave.
Carlsbad,  CA  92008
Applicant Contact CAROL WHITE
Correspondent
Calcitek, Inc.
2320 Faraday Ave.
Carlsbad,  CA  92008
Correspondent Contact CAROL WHITE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/28/1994
Decision Date 11/15/1995
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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