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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K982400
Device Name STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT
Applicant
Steri-Oss, Inc.
22895 Eastpark Dr.
Yorba Linda,  CA  92887
Applicant Contact JEFF HAUSHEER
Correspondent
Steri-Oss, Inc.
22895 Eastpark Dr.
Yorba Linda,  CA  92887
Correspondent Contact JEFF HAUSHEER
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/10/1998
Decision Date 09/23/1998
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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