免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

EDS 鈣鹼軟化器 TURBO CR

K 號：K223340 · 2023-12-11

申請人Essential Dental Systems, Inc.
決定日期2023-12-11
產品代碼ELC
諮詢委員會DE
決定相當於

器材摘要

EDS Calculus Softener TURBO CR is the device name listed in this FDA 510(k) record. The listed applicant is Essential Dental Systems, Inc.. It received FDA 510(k) clearance on 2023-12-11 under 510(k) number K223340. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EDS Calculus Softener TURBO CR?

EDS Calculus Softener TURBO CR is a medical device that received FDA 510(k) clearance on 2023-12-11. The listed applicant is Essential Dental Systems, Inc.. The 510(k) number is K223340.

When did EDS Calculus Softener TURBO CR receive FDA 510(k) clearance?

EDS Calculus Softener TURBO CR received FDA 510(k) clearance on 2023-12-11, under 510(k) number K223340.

Who is the listed applicant for EDS Calculus Softener TURBO CR?

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

What is the FDA product code for EDS Calculus Softener TURBO CR?

The FDA product code for EDS Calculus Softener TURBO CR is ELC.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Essential Dental Systems, 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。

K152691EDS大眾水泥

相關器械（代碼：ELC）

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。

K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT機器空氣流預防主機E.M.S Electro Medical Systems S.AK251689VARIOS 170 LUX 計量系統 (VA170LUXS10)；VARIOS 170 LUX 計量系統 (VA170LUXS11)；VARIOS 170 計量系統 (VA170S11)Nakanishi, Inc.K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.K233844OdneCleanOdne AGK240707超聲刮牙器（WD-JY-B002、WD-JY-W001、WD-JY-R003、WD-JY-G004、WD-JY-B003、WD-JY-C006、WD-JY-M0014、WD-JY-N0015、WD-JY-N0016、WD-JY-N0017、WD-JY-E007、WD-JY-F008、WD-JY-A005、WD-JY-H009、WD-JY-I0011、WD-JY-K0012、WD-JY-K0013、WD-JY-K0014、WD-JY-L0013、WD-JY-L0014、WD-JY-L0015、WD-JY-L0016、WD-JY-L0017）Shenzhen Micro Electric Intelligence Co., Ltd.

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。

↑