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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 K884845
Device Name STERI-OSS
Applicant
Denar Corp.
901 E. Cerritos Ave.
Anaheim,  CA  92805
Applicant Contact STEVE HURSON
Correspondent
Denar Corp.
901 E. Cerritos Ave.
Anaheim,  CA  92805
Correspondent Contact STEVE HURSON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/21/1988
Decision Date 02/10/1989
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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