FDA 510(k)

现有 BioHorizons 牙种植体和基台兼容 MRI

K号: K223697 · 2023-10-13

决定日期2023-10-13

产品代码DZE

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决定实质等同

器械摘要

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.

常见问题

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.

列明BioHorizons Implant Systems, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260061BioHorizons CEREC 兼容 Ti-Bases K243521锥形钛基托 K240531SmartShape®修复基台；宽定制铣削Ti-Blank基台 K240187锥形植入系统 K203252针对CONELOG的多单位基台 K182070BioHorizons Tapered IM Implants

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。