FDA 510(k)

Obsidian® NOW

K 號：K234014 · 2024-02-27

決定日期2024-02-27

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Obsidian® NOW is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2024-02-27 under 510(k) number K234014. 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 Obsidian® NOW?

Obsidian® NOW is a medical device that received FDA 510(k) clearance on 2024-02-27. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K234014.

When did Obsidian® NOW receive FDA 510(k) clearance?

Obsidian® NOW received FDA 510(k) clearance on 2024-02-27, under 510(k) number K234014.

Who is the listed applicant for Obsidian® NOW?

FDA 510(k) 記錄將 Prismatik Dentalcraft, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Obsidian® NOW?

The FDA product code for Obsidian® NOW is EIH.

其他以 Prismatik Dentalcraft, Inc. 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。

K261802Glidewell™ 牙托基材膠 K262239Obsidian® 压克力壓克力超過鎂鋁 K254283BruxZir® 遮光 16 PLUS K252582Inclusive® 钛金牙根座，相容於：Camlog® CONELOG® 植牙系統，Dentium® NR Line 植牙系統 K252446BruxZir® 現在 K250302彈性局部樹脂

查看所有 37 項裝置 →

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 K260918佐立隆尼士Amann Girrbach AG K260859羅塞塔SM，羅塞塔SPHass Corp.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。