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FDA 510(k)

海神

K 號：K211813 · 2021-08-18

申請人Inter-Med / Vista Dental
決定日期2021-08-18
產品代碼KJJ
決定相當於

器材摘要

Triton is the device name listed in this FDA 510(k) record. The listed applicant is Inter-Med / Vista Dental. It received FDA 510(k) clearance on 2021-08-18 under 510(k) number K211813. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

常見問題

What is the Triton?

Triton is a medical device that received FDA 510(k) clearance on 2021-08-18. The listed applicant is Inter-Med / Vista Dental. The 510(k) number is K211813.

When did Triton receive FDA 510(k) clearance?

Triton received FDA 510(k) clearance on 2021-08-18, under 510(k) number K211813.

Who is the listed applicant for Triton?

The FDA 510(k) record lists Inter-Med / Vista Dental as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triton?

The FDA product code for Triton is KJJ.

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

相關器械（代碼：KJJ）

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。

K250279RC-SwiftPrepBelport Company, Inc., Gingi-PakK241354密封劑溶劑Inter-Med, Inc.K201785EPIEN 牙齒清潔器Epien Medical, Inc.K193357V-MixInter-Med/Vista Dental ProductsK193409視野清潔器，視野清潔器加強版Inter-Med/Vista Dental ProductsK200330RC-Prime根管準備膠膏Pac-Dent, Inc.

官方來源

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