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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 K992538
Device Name AMORPHOUS DIAMOND COATED SCREW
Applicant
Nobel Biocare Uas, Inc.
22895 Eastpark Dr.
Yorba Linda,  CA  92887
Applicant Contact KIM RENDON
Correspondent
Nobel Biocare Uas, Inc.
22895 Eastpark Dr.
Yorba Linda,  CA  92887
Correspondent Contact KIM RENDON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/30/1999
Decision Date 11/23/1999
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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