FDA 510(k)

SHOFU 树脂膚釉

K 號：K163568 · 2017-08-16

決定日期2017-08-16

產品代碼EBD

諮詢委員會DE

決定相當於

器材摘要

SHOFU RESIN GLAZE is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2017-08-16 under 510(k) number K163568. 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 SHOFU RESIN GLAZE?

SHOFU RESIN GLAZE is a medical device that received FDA 510(k) clearance on 2017-08-16. The listed applicant is Shofu Dental Corporation. The 510(k) number is K163568.

When did SHOFU RESIN GLAZE receive FDA 510(k) clearance?

SHOFU RESIN GLAZE received FDA 510(k) clearance on 2017-08-16, under 510(k) number K163568.

Who is the listed applicant for SHOFU RESIN GLAZE?

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

What is the FDA product code for SHOFU RESIN GLAZE?

The FDA product code for SHOFU RESIN GLAZE is EBD.

其他以 Shofu Dental Corporation 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 K223365RODIN 色彩自然化套件Belport Company, Inc., Gingi-Pak K211854VITA Akzent LCVita Zahnfabrik GmbH H Rauter & CO K162408奈米膠漆，表面膠質，表面光繪Dreve Dentamid GmbH

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