FDA 510(k)

Neodent植牙系統-橋梁用GM钛金底座

K 號：K192229 · 2019-12-19

申請人Jjgc Industria E Comercio DE Materiais Dentarios S.A.

決定日期2019-12-19

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Neodent Implant System- GM Titanium Base for Bridge is the device name listed in this FDA 510(k) record. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K192229. 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 Neodent Implant System- GM Titanium Base for Bridge?

Neodent Implant System- GM Titanium Base for Bridge is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K192229.

When did Neodent Implant System- GM Titanium Base for Bridge receive FDA 510(k) clearance?

Neodent Implant System- GM Titanium Base for Bridge received FDA 510(k) clearance on 2019-12-19, under 510(k) number K192229.

Who is the listed applicant for Neodent Implant System- GM Titanium Base for Bridge?

The FDA 510(k) record lists Jjgc Industria E Comercio DE Materiais Dentarios S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent Implant System- GM Titanium Base for Bridge?

The FDA product code for Neodent Implant System- GM Titanium Base for Bridge is NHA.

其他以 Jjgc Industria E Comercio DE Materiais Dentarios S.A. 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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