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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 K970073
Device Name BIO-ESTHETIC INDIRECT ABUTMENT
Applicant
STERI-OSS, INC.
22895 EASTPARK DR.
YORBA LINDA,  CA  92887
Applicant Contact JEFF HAUSHEER, PH.D.
Correspondent
STERI-OSS, INC.
22895 EASTPARK DR.
YORBA LINDA,  CA  92887
Correspondent Contact JEFF HAUSHEER, PH.D.
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/08/1997
Decision Date 07/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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