FDA 510(k)

生物地平線 CEREC 兼容 Ti-Bases

K 號：K260061 · 2026-06-26

決定日期2026-06-26

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 BioHorizons Implant Systems, Inc. 為申請人之記錄

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相關器械（代碼：NHA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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