FDA 510(k)

Copra Smile, Copra Supreme Hyperion

K 號：K233158 · 2024-06-20

決定日期2024-06-20

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Copra Smile, Copra Supreme Hyperion is the device name listed in this FDA 510(k) record. The listed applicant is Whitepeaks Dental Solutions GmbH. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K233158. 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 Copra Smile, Copra Supreme Hyperion?

Copra Smile, Copra Supreme Hyperion is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Whitepeaks Dental Solutions GmbH. The 510(k) number is K233158.

When did Copra Smile, Copra Supreme Hyperion receive FDA 510(k) clearance?

Copra Smile, Copra Supreme Hyperion received FDA 510(k) clearance on 2024-06-20, under 510(k) number K233158.

Who is the listed applicant for Copra Smile, Copra Supreme Hyperion?

The FDA 510(k) record lists Whitepeaks Dental Solutions GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Copra Smile, Copra Supreme Hyperion?

The FDA product code for Copra Smile, Copra Supreme Hyperion is EIH.

其他以 Whitepeaks Dental Solutions GmbH 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。

K233064Copra Supreme K232952科普蘭 Zri

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。