FDA 510(k)

Elos精準雙模組基座

K 號：K230317 · 2023-09-01

決定日期2023-09-01

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Elos Accurate Hybrid Base is the device name listed in this FDA 510(k) record. The listed applicant is Elos Medtech Pinol A/S. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K230317. 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 Elos Accurate Hybrid Base?

Elos Accurate Hybrid Base is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Elos Medtech Pinol A/S. The 510(k) number is K230317.

When did Elos Accurate Hybrid Base receive FDA 510(k) clearance?

Elos Accurate Hybrid Base received FDA 510(k) clearance on 2023-09-01, under 510(k) number K230317.

Who is the listed applicant for Elos Accurate Hybrid Base?

The FDA 510(k) record lists Elos Medtech Pinol A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elos Accurate Hybrid Base?

The FDA product code for Elos Accurate Hybrid Base is NHA.

其他以 Elos Medtech Pinol A/S 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。

K253774Elos Accurate® 牙齒固定系統 K251497Elos精準雙模組基座 K242025Elos Accurate®雙模組基座™K241722Elos Accurate®雙模組基座™；Elos Accurate®客製化牙托 K231307Elos精準客製式牙根台 K222044Elos精準客製式牙根台

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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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