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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 K172576
Device Name BioHorizons Tapered Short Implants
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 Number872.3640
Classification Product Code
DZE  
Date Received08/28/2017
Decision Date 11/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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