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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, Orthodontic
510(k) Number K081393
Device Name ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW
Applicant
G & H Wire Co.
11460 N.Meridian St.,
Suite 150
Carmel,  IN  46032
Applicant Contact CARRI GRAHAM
Correspondent
G & H Wire Co.
11460 N.Meridian St.,
Suite 150
Carmel,  IN  46032
Correspondent Contact CARRI GRAHAM
Regulation Number872.3640
Classification Product Code
OAT  
Date Received05/19/2008
Decision Date 08/21/2008
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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