FDA 510(k)

INNO SLA 潜沉式雙金屬Ti基礎系統

K 號：K231411 · 2023-12-20

決定日期2023-12-20

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

INNO SLA Submerged Hybrid Ti-Base System is the device name listed in this FDA 510(k) record. The listed applicant is Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K231411. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the INNO SLA Submerged Hybrid Ti-Base System?

INNO SLA Submerged Hybrid Ti-Base System is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Cowellmedi Co., Ltd.. The 510(k) number is K231411.

When did INNO SLA Submerged Hybrid Ti-Base System receive FDA 510(k) clearance?

INNO SLA Submerged Hybrid Ti-Base System received FDA 510(k) clearance on 2023-12-20, under 510(k) number K231411.

Who is the listed applicant for INNO SLA Submerged Hybrid Ti-Base System?

The FDA 510(k) record lists Cowellmedi Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNO SLA Submerged Hybrid Ti-Base System?

The FDA product code for INNO SLA Submerged Hybrid Ti-Base System is NHA.

其他以 Cowellmedi Co., Ltd. 為申請人之記錄

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相關器械（代碼：NHA）

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。

K262207固定式加長基座Unidental Co., Ltd.K260940貝拉特克條ZimVie US Corp, LLC K253999通用基座 ASC 接合；通用基座 ASC 非接合；通用基座 MUA ASC；臨時基座接合和非接合；恢復基座極锥連接；Omnigrip臨床螺釘鈦金；Omnigrip假牙螺釘Nobel Biocare AB K261147Neodent植牙系統 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061生物地平線 CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

官方來源

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