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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 NORTH MERIDIAN STREET
SUITE 150
CARMEL,  IN  46032
Applicant Contact CARRI GRAHAM
Correspondent
G & H WIRE CO.
11460 NORTH MERIDIAN STREET
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
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