FDA 510(k)

EK多角度30牙根座

K 號：K251427 · 2026-01-29

決定日期2026-01-29

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

EK MULTI ANGLED 30 ABUTMENT is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K251427. 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 EK MULTI ANGLED 30 ABUTMENT?

EK MULTI ANGLED 30 ABUTMENT is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is Hiossen, Inc.. The 510(k) number is K251427.

When did EK MULTI ANGLED 30 ABUTMENT receive FDA 510(k) clearance?

EK MULTI ANGLED 30 ABUTMENT received FDA 510(k) clearance on 2026-01-29, under 510(k) number K251427.

Who is the listed applicant for EK MULTI ANGLED 30 ABUTMENT?

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

What is the FDA product code for EK MULTI ANGLED 30 ABUTMENT?

The FDA product code for EK MULTI ANGLED 30 ABUTMENT is NHA.

其他以 Hiossen, 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。

K253372ET治療基座；ET掃描治療基座；EK掃描治療基座 K241003HIOSSEN 預製基座（ET 預製基座 & EK 預製基座）K240232EK D3.3 及超廣角植入體 K233389EK數位牙根支台 K222636ET牙根擴張系統 K203360EK植入體及基座系統

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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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