FDA 510(k)

BA 牙齒溝縫密封劑

K 號：K190998 · 2019-11-08

決定日期2019-11-08

產品代碼EBC

諮詢委員會DE

決定相當於

器材摘要

BA Pit & Fissure Sealant is the device name listed in this FDA 510(k) record. The listed applicant is Apex Dental Materials, Inc.. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K190998. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BA Pit & Fissure Sealant?

BA Pit & Fissure Sealant is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Apex Dental Materials, Inc.. The 510(k) number is K190998.

When did BA Pit & Fissure Sealant receive FDA 510(k) clearance?

BA Pit & Fissure Sealant received FDA 510(k) clearance on 2019-11-08, under 510(k) number K190998.

Who is the listed applicant for BA Pit & Fissure Sealant?

The FDA 510(k) record lists Apex Dental Materials, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BA Pit & Fissure Sealant?

The FDA product code for BA Pit & Fissure Sealant is EBC.

其他以 Apex Dental Materials, 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。

K161077研發TE和研發SE

相關器械（代碼：EBC）

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。

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官方來源

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