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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 K980620
Device Name DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM
Applicant
Dentatus USA , Ltd.
192 Lexington Ave.
New York,  NY  10016
Applicant Contact STEPHEN B RUBINSKY
Correspondent
Dentatus USA , Ltd.
192 Lexington Ave.
New York,  NY  10016
Correspondent Contact STEPHEN B RUBINSKY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/18/1998
Decision Date 05/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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