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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 K984198
Device Name WIDE BODY ABUTMENTS
Applicant
Vident
3150 E. Birch St.
Brea,  CA  92821
Applicant Contact BARBARA J LEWANDOWSKI
Correspondent
Vident
3150 E. Birch St.
Brea,  CA  92821
Correspondent Contact BARBARA J LEWANDOWSKI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/24/1998
Decision Date 02/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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