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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 K173701
Device Name Implant-One System
Applicant
Implant Logistics, Inc.
3rd St. S.
La Crosse,  WI  54601
Applicant Contact Thomas Arendt
Correspondent
Backroads Consulting, Inc.
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/04/2017
Decision Date 11/29/2018
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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