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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 the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) 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. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K223697.

When did MRI compatibility for existing BioHorizons dental implants and abutments receive FDA 510(k) clearance?

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

Who is the listed applicant for MRI compatibility for existing BioHorizons dental implants and abutments?

The FDA 510(k) record lists BioHorizons Implant Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03917927A Clinical Study of the Eztetic Dental Implant SystemCOMPLETEDNCT05883202Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental ImplantsSUSPENDEDNCT06948162Exploration of the Utility of Dental-dedicated MRI for DentistryRECRUITINGNCT07246499Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.COMPLETEDNCT07714265Soft Tissue Augmentation Around Dental Implants Using Connective Tissue Graft, Submerged Tenting Abutment, or Sub-crestal Implant PlacementRECRUITINGNCT07777562Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.NOT_YET_RECRUITING

Other records listing BioHorizons Implant Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260061BioHorizons CEREC Compatible Ti-BasesK243521Conical Ti Base abutmentsK240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentK240187Tapered Pro Conical Implant SystemK203252Multi-unit Abutments for CONELOGK182070BioHorizons Tapered IM Implants

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , 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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