FDA 510(k)

BruxZir® 現在

K 號：K252446 · 2025-09-03

決定日期2025-09-03

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

BruxZir® 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 2025-09-03 under 510(k) number K252446. 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 BruxZir® NOW?

BruxZir® NOW is a medical device that received FDA 510(k) clearance on 2025-09-03. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K252446.

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

BruxZir® NOW received FDA 510(k) clearance on 2025-09-03, under 510(k) number K252446.

Who is the listed applicant for BruxZir® 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 BruxZir® NOW?

The FDA product code for BruxZir® 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 K250302彈性局部樹脂 K242564可蒸氣滅菌卡匣 (Glidewell HT™ 植入導引外科工具包, Glidewell HT™ 植入外科工具包, Glidewell™ 假牙工具包)

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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。