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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 K964944
Device Name ROUND DENTAL BUR
Applicant
Steri-Oss, Inc.
22895 Eastpark Dr.
Yorba Linda,  CA  92887
Applicant Contact JEFF AHUSHEER, PH.D.
Correspondent
Steri-Oss, Inc.
22895 Eastpark Dr.
Yorba Linda,  CA  92887
Correspondent Contact JEFF AHUSHEER, PH.D.
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/10/1996
Decision Date 02/10/1997
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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