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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 K991822
Device Name ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH
Applicant
Dr. Ihde Dental AG Switzerland
Battery Pl. 70, Riverwatch
Suite 406
New York,  NY  10280
Applicant Contact MOURAD BARAKET
Correspondent
Dr. Ihde Dental AG Switzerland
Battery Pl. 70, Riverwatch
Suite 406
New York,  NY  10280
Correspondent Contact MOURAD BARAKET
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/27/1999
Decision Date 08/15/2001
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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