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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 K023067
Device Name IMTEC SENDAX MDI ORTHO6 AND ORTHO8
Applicant
Imtec Corp.
2401 N Commerce
Ardmore,  OK  73401
Applicant Contact BRAD VANCE
Correspondent
Imtec Corp.
2401 N Commerce
Ardmore,  OK  73401
Correspondent Contact BRAD VANCE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/16/2002
Decision Date 12/03/2002
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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