FDA 510(k)

佐立隆尼士

K 號：K260918 · 2026-06-29

決定日期2026-06-29

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Zolid Lunaris is the device name listed in this FDA 510(k) record. The listed applicant is Amann Girrbach AG. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K260918. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zolid Lunaris?

Zolid Lunaris is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Amann Girrbach AG. The 510(k) number is K260918.

When did Zolid Lunaris receive FDA 510(k) clearance?

Zolid Lunaris received FDA 510(k) clearance on 2026-06-29, under 510(k) number K260918.

Who is the listed applicant for Zolid Lunaris?

The FDA 510(k) record lists Amann Girrbach AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zolid Lunaris?

The FDA product code for Zolid Lunaris is EIH.

其他以 Amann Girrbach AG 為申請人之記錄

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。

K191836瓷美爾 A-Splint K191843瓷美儂 A-Temp K171876瓷美 Zolid HT+ 白色

相關器械（代碼：EIH）

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。

K262074任何-錫科斯Mediclus Co., Ltd.K262239Obsidian® 压克力壓克力超過鎂鋁Prismatik Dentalcraft, Inc.K261046牙醫用氧化鋁陶瓷空白片及上色液Hunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy陶瓷染色及釉料Zima International Inc., dba Dandy K260859羅塞塔SM，羅塞塔SPHass Corp.K253191DCMhotbond 鈦石Dental Creativ Management GmbH

官方來源

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