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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 K925555
Device Name STERI-OSS THREADED TPS HEX SERIES IMPLANT
Applicant
Steri-Oss, Inc.
901 E. Cerritos Ave.
Anaheim,  CA  92805
Applicant Contact DON KENNARD
Correspondent
Steri-Oss, Inc.
901 E. Cerritos Ave.
Anaheim,  CA  92805
Correspondent Contact DON KENNARD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/03/1992
Decision Date 09/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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