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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K063768
Device Name TITANIUM SCALLOPED ABUTMENT
Applicant
VIDENT
3150 EAST BIRCH ST.
BREA,  CA  92821
Applicant Contact ELIZABETH WOLFSEN
Correspondent
VIDENT
3150 EAST BIRCH ST.
BREA,  CA  92821
Correspondent Contact ELIZABETH WOLFSEN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/20/2006
Decision Date 06/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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