FDA 510(k)

奈米膠漆，表面膠質，表面光繪

K 號：K162408 · 2018-04-05

決定日期2018-04-05

產品代碼EBD

諮詢委員會DE

決定相當於

器材摘要

Nano Varnish, Plaquit, Lightpaint on Surface is the device name listed in this FDA 510(k) record. The listed applicant is Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K162408. 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 Nano Varnish, Plaquit, Lightpaint on Surface?

Nano Varnish, Plaquit, Lightpaint on Surface is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Dreve Dentamid GmbH. The 510(k) number is K162408.

When did Nano Varnish, Plaquit, Lightpaint on Surface receive FDA 510(k) clearance?

Nano Varnish, Plaquit, Lightpaint on Surface received FDA 510(k) clearance on 2018-04-05, under 510(k) number K162408.

Who is the listed applicant for Nano Varnish, Plaquit, Lightpaint on Surface?

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

What is the FDA product code for Nano Varnish, Plaquit, Lightpaint on Surface?

The FDA product code for Nano Varnish, Plaquit, Lightpaint on Surface is EBD.

其他以 Dreve Dentamid 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。

K250739Primeprint直接對齊器 K200580FotoDent 牙齒假牙 K190571石咬與石咬掃描 K171562Dynax透明，Dynax膠泥，Dynax重質地，Dynax輕質地，Dynax單色 K171729Fixtemp C&B

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 K163568SHOFU 树脂膚釉Shofu Dental Corporation

官方來源

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