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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 K180998
Device Name BioHorizons CAD/CAM Bars
Applicant
BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham,  AL  35244
Applicant Contact Michael Davis
Correspondent
BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham,  AL  35244
Correspondent Contact Michael Davis
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/16/2018
Decision Date 09/28/2018
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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