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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 K974401
Device Name 4.0MM SIMPLER ONE THREADED DENTAL IMPLANT
Applicant
Vancouver Implant Resources, Inc.
2370 Maple St.
Vancouver, Bc,,  CA V6J 3T6
Applicant Contact HAROLD BERGMAN
Correspondent
Vancouver Implant Resources, Inc.
2370 Maple St.
Vancouver, Bc,,  CA V6J 3T6
Correspondent Contact HAROLD BERGMAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/21/1997
Decision Date 02/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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