BioHorizons Implant Systems, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
BioHorizons Implant Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Conical Ti Base abutments, SmartShape™ Healing Abutment, Tapered Pro Conical Implant System
41
Total
41
Cleared
0
Denied
BioHorizons Implant Systems, Inc. has 41 FDA 510(k) cleared dental devices. Based in Birmingham, US.
Latest FDA clearance: Jun 2026. Active since 1996.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by PaxMed International, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - BioHorizons Implant Systems, Inc.
41 devices
Cleared
Jun 26, 2026
BioHorizons CEREC Compatible Ti-Bases (TP3CTB1~PBCTB3 and CNTE0~CRTE2)
Dental
169d
Cleared
May 01, 2025
Conical Ti Base abutments
Dental
169d
Cleared
Jul 30, 2024
SmartShape™ Healing Abutment
Dental
158d
Cleared
Jun 05, 2024
Tapered Pro Conical Implant System
Dental
133d
Cleared
Oct 13, 2023
MRI compatibility for existing BioHorizons dental implants and abutments
Dental
308d
Cleared
Mar 16, 2021
Multi-unit Abutments for CONELOG
Dental
132d
Cleared
Oct 10, 2018
BioHorizons Tapered IM Implants
Dental
70d
Cleared
Sep 28, 2018
BioHorizons CAD/CAM Bars
Dental
165d
Cleared
Nov 22, 2017
BioHorizons Tapered Short Implants
Dental
86d
Cleared
Jan 13, 2016
BioHorizons CAD/CAM Abutments
Dental
211d
Cleared
Jan 08, 2015
BioHorizons Tapered Internal Implants
Dental
79d
Cleared
Sep 05, 2012
BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
Dental
79d
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