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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 K990277
Device Name O-RING ABUTMENT
Applicant
BioHorizons Implant Systems, Inc.
One Perimeter Park S.
Suite 230, S.
Birmingham,  AL  35243
Applicant Contact DIANA M EASTON
Correspondent
BioHorizons Implant Systems, Inc.
One Perimeter Park S.
Suite 230, S.
Birmingham,  AL  35243
Correspondent Contact DIANA M EASTON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/28/1999
Decision Date 04/09/1999
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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