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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 K031106
Device Name IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX
Applicant
Imtec Corp.
2401 N Commerce
Ardmore,  OK  73401
Applicant Contact J. BRAD VANCE
Correspondent
Imtec Corp.
2401 N Commerce
Ardmore,  OK  73401
Correspondent Contact J. BRAD VANCE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/08/2003
Decision Date 08/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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