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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 K920909
Device Name HEXLOCK SCREW
Applicant
Imtec Corp.
2007 N. Commerce
P.O. Box 1562
Ardmore,  OK  73402
Applicant Contact GILLESPIE
Correspondent
Imtec Corp.
2007 N. Commerce
P.O. Box 1562
Ardmore,  OK  73402
Correspondent Contact GILLESPIE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/27/1992
Decision Date 01/12/1993
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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