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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K990846
Device Name AMORPHOUS DIAMOND COATED DRILL
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 Number872.4120
Classification Product Code
DZI  
Date Received03/15/1999
Decision Date 06/10/1999
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
Recalls CDRH Recalls
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