FDA 510(k)

BruxZir® 現今 SRC

K 號：K231940 · 2024-05-15

決定日期2024-05-15

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

BruxZir® NOW SRC 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 2024-05-15 under 510(k) number K231940. 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 BruxZir® NOW SRC?

BruxZir® NOW SRC is a medical device that received FDA 510(k) clearance on 2024-05-15. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K231940.

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

BruxZir® NOW SRC received FDA 510(k) clearance on 2024-05-15, under 510(k) number K231940.

Who is the listed applicant for BruxZir® NOW SRC?

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 SRC?

The FDA product code for BruxZir® NOW SRC is NHA.

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

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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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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。