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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 K072660
Device Name ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114
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 Received09/21/2007
Decision Date 12/12/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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