FDA 510(k)

BioHorizons Tapered Short Implants

K号: K172576 · 2017-11-22

决定日期2017-11-22

产品代码DZE

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决定实质等同

器械摘要

BioHorizons Tapered Short Implants 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 2017-11-22 under 510(k) number K172576. 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 BioHorizons Tapered Short Implants?

BioHorizons Tapered Short Implants is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K172576.

When did BioHorizons Tapered Short Implants receive FDA 510(k) clearance?

BioHorizons Tapered Short Implants received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172576.

Who is the listed applicant for BioHorizons Tapered Short Implants?

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 BioHorizons Tapered Short Implants?

The FDA product code for BioHorizons Tapered Short Implants 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 K223697现有 BioHorizons 牙种植体和基台兼容 MRI K203252针对CONELOG的多单位基台

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