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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 K240531
Device Name SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment
Applicant
BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham,  AL  35244
Applicant Contact Jared Cooper
Correspondent
BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham,  AL  35244
Correspondent Contact Jared Cooper
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/23/2024
Decision Date 07/30/2024
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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