FDA 510(k)

BioHorizons CEREC 兼容 Ti-Bases

K号: K260061 · 2026-06-26

决定日期2026-06-26

产品代码NHA

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决定实质等同

器械摘要

BioHorizons CEREC Compatible Ti-Bases 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 2026-06-26 under 510(k) number K260061. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BioHorizons CEREC Compatible Ti-Bases?

BioHorizons CEREC Compatible Ti-Bases is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K260061.

When did BioHorizons CEREC Compatible Ti-Bases receive FDA 510(k) clearance?

BioHorizons CEREC Compatible Ti-Bases received FDA 510(k) clearance on 2026-06-26, under 510(k) number K260061.

Who is the listed applicant for BioHorizons CEREC Compatible Ti-Bases?

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 CEREC Compatible Ti-Bases?

The FDA product code for BioHorizons CEREC Compatible Ti-Bases is NHA.

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。

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相关器械（代码：NHA）

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。

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