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FDA 510(k)

MRI compatibility for existing BioHorizons dental implants and abutments

K-Number: K223697 · 2023-10-13

ApplicantBioHorizons Implant Systems, Inc.
Decision Date2023-10-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MRI compatibility for existing BioHorizons dental implants and abutments is a medical device manufactured by BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2023-10-13 under approval number K223697. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRI compatibility for existing BioHorizons dental implants and abutments?

MRI compatibility for existing BioHorizons dental implants and abutments is a medical device that received FDA 510(k) clearance on 2023-10-13. It is manufactured by BioHorizons Implant Systems, Inc.. The 510(k) number is K223697.

When was MRI compatibility for existing BioHorizons dental implants and abutments approved by the FDA?

MRI compatibility for existing BioHorizons dental implants and abutments received FDA 510(k) clearance on 2023-10-13, under approval number K223697.

What company makes MRI compatibility for existing BioHorizons dental implants and abutments?

MRI compatibility for existing BioHorizons dental implants and abutments is manufactured by BioHorizons Implant Systems, Inc..

What is the FDA product code for MRI compatibility for existing BioHorizons dental implants and abutments?

The FDA product code for MRI compatibility for existing BioHorizons dental implants and abutments is DZE.

Related Clinical Trials

NCT07608523 Marginal Bone Level Around Dental Implants in Periodontitis Patients COMPLETED NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT06948162 Exploration of the Utility of Dental-dedicated MRI for Dentistry RECRUITING NCT07589140 Influence of Alveolar Bone Drilling and Anatomical Position on Integration NOT_YET_RECRUITING NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT07240493 BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement COMPLETED

Related PubMed Literature

PMID: 40781789 Resorbable Bio-Inductive Collagen Implant for Rotator Cuff Repair: What We Know, What We Need to Know, and the Path Forward. Orthopaedic surgery (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by BioHorizons Implant Systems, Inc.

K151621BioHorizons CAD/CAM Abutments K172576BioHorizons Tapered Short Implants K182070BioHorizons Tapered IM Implants K180998BioHorizons CAD/CAM Bars K203252Multi-unit Abutments for CONELOG K240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment

View all 9 devices →

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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