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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 K060376
Device Name SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24
Applicant
Simpler Implant, Inc.
404-1023 Wolfe Ave.
Vancouver, Bc,  CA V6H 1V6
Applicant Contact KAREN BERGMAN
Correspondent
Simpler Implant, Inc.
404-1023 Wolfe Ave.
Vancouver, Bc,  CA V6H 1V6
Correspondent Contact KAREN BERGMAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/14/2006
Decision Date 04/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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