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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 K073461
Device Name ORTHO ANCHOR SCREWS
Applicant
M.I.S. IMPLANTS TECHNOLOGIES LTD.
P.O.B. 110
SHLOMI INDUSTRIAL ZONE
SHLOMI,  IL 22832
Applicant Contact IMAN KHORSHID
Correspondent
M.I.S. IMPLANTS TECHNOLOGIES LTD.
P.O.B. 110
SHLOMI INDUSTRIAL ZONE
SHLOMI,  IL 22832
Correspondent Contact IMAN KHORSHID
Regulation Number872.3640
Classification Product Code
OAT  
Date Received12/10/2007
Decision Date 01/25/2008
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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