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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 K905223
Device Name OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS
Applicant
UNIVERSAL IMPLANT SYSTEMS, INC.
4400 jenifer street, n.w.
suite 220
washington,  DC  20015
Applicant Contact gerald marlin
Correspondent
UNIVERSAL IMPLANT SYSTEMS, INC.
4400 jenifer street, n.w.
suite 220
washington,  DC  20015
Correspondent Contact gerald marlin
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/20/1990
Decision Date 08/16/1991
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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