FDA 510(k)

Glidewell™ 3DP 牙托基材膠

K 號：K241493 · 2024-09-12

決定日期2024-09-12

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Glidewell™ 3DP Denture Base Resin 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 2024-09-12 under 510(k) number K241493. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Glidewell™ 3DP Denture Base Resin?

Glidewell™ 3DP Denture Base Resin is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K241493.

When did Glidewell™ 3DP Denture Base Resin receive FDA 510(k) clearance?

Glidewell™ 3DP Denture Base Resin received FDA 510(k) clearance on 2024-09-12, under 510(k) number K241493.

Who is the listed applicant for Glidewell™ 3DP Denture Base Resin?

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 Glidewell™ 3DP Denture Base Resin?

The FDA product code for Glidewell™ 3DP Denture Base Resin is EBI.

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：EBI）

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Prismatik Dentalcraft, Inc.K261626超印柔軟假牙紫外線Guangzhou Heygears IMC., Inc.K262681奈米瓷膠膠黏劑3BFAB TEKNOLOJI A.S.K262300假牙基座膠 V2Formlabs Ohio, Inc.K261474DENTCA 真柔軟Dentca, Inc.K260569DB 4000 高衝擊牙托基座Carbon, Inc.

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。