FDA 510(k)

RODIN 色彩自然化套件

K 號：K223365 · 2023-03-27

決定日期2023-03-27

產品代碼EBD

諮詢委員會DE

決定相當於

器材摘要

RODIN Palette Naturalizing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2023-03-27 under 510(k) number K223365. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RODIN Palette Naturalizing Kit?

RODIN Palette Naturalizing Kit is a medical device that received FDA 510(k) clearance on 2023-03-27. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K223365.

When did RODIN Palette Naturalizing Kit receive FDA 510(k) clearance?

RODIN Palette Naturalizing Kit received FDA 510(k) clearance on 2023-03-27, under 510(k) number K223365.

Who is the listed applicant for RODIN Palette Naturalizing Kit?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RODIN Palette Naturalizing Kit?

The FDA product code for RODIN Palette Naturalizing Kit is EBD.

其他以 Belport Company, Inc., Gingi-Pak 為申請人之記錄

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相關器械（代碼：EBD）

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。

K254091亮麗塗層（15ML）YAMAHACHI DENTAL MFG., Co.K250804ID 照明治療系統Id Korea Co., Ltd.K240735visio.lign 颜色，visio.lign 盾Bredent GmbH & Co. KG K211854VITA Akzent LCVita Zahnfabrik GmbH H Rauter & CO K162408奈米膠漆，表面膠質，表面光繪Dreve Dentamid GmbH K163568SHOFU 树脂膚釉Shofu Dental Corporation

官方來源

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