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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 K912262
Device Name HEXLOCK
Applicant
IMTEC CORP.
5 "a" st., n.w. - suite 2
ardmore,  OK  73401
Applicant Contact gillespie
Correspondent
IMTEC CORP.
5 "a" st., n.w. - suite 2
ardmore,  OK  73401
Correspondent Contact gillespie
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/22/1991
Decision Date 12/10/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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