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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 K850706
Device Name F-SERIES IMPLANT
Applicant
Omni Intl., Inc.
1100 N. Florida Ave.
Tampa,  FL  33602
Applicant Contact ROBERT M HATFIELD
Correspondent
Omni Intl., Inc.
1100 N. Florida Ave.
Tampa,  FL  33602
Correspondent Contact ROBERT M HATFIELD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/22/1985
Decision Date 04/10/1985
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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