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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 K960900
Device Name IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW
Applicant
Imcor
5763 Long Brake Cir.
Edina,  MN  55439
Applicant Contact ROBERT S URA
Correspondent
Imcor
5763 Long Brake Cir.
Edina,  MN  55439
Correspondent Contact ROBERT S URA
Regulation Number872.3640
Classification Product Code
DZE  
Date Received03/05/1996
Decision Date 06/05/1996
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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