FDA 510(k)

GBR系統

K 號：K233419 · 2025-01-03

申請人Proimtech Saglik Urunleri Anonim Sirketi

決定日期2025-01-03

產品代碼DZL

諮詢委員會DE

決定相當於

器材摘要

GBR System is the device name listed in this FDA 510(k) record. The listed applicant is Proimtech Saglik Urunleri Anonim Sirketi. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K233419. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GBR System?

GBR System is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Proimtech Saglik Urunleri Anonim Sirketi. The 510(k) number is K233419.

When did GBR System receive FDA 510(k) clearance?

GBR System received FDA 510(k) clearance on 2025-01-03, under 510(k) number K233419.

Who is the listed applicant for GBR System?

The FDA 510(k) record lists Proimtech Saglik Urunleri Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GBR System?

The FDA product code for GBR System is DZL.

其他以 Proimtech Saglik Urunleri Anonim Sirketi 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。

K231502迷你螺釘 K231100Proimtech 齒科身體植入物，Proimtech 牙根帽，Proimtech 恢復帽，Proimtech 牙根帽螺釘

相關器械（代碼：DZL）

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。

K254286導骨再生系統DentalMaster(Xiamen)Medical Technology Co., Ltd.K250123Master-Pin X (帶絲牙的MP釘針) (36BMP000030 / MP30)Hager& Meisinger GmbH K251569骨釘Osstem Implant Co., Ltd.K243190自訂骨固定/骨增強系統 - PINUstomed Instrumente Ulrich Storz GmbH & Co. KG K240321MP 平面釘無絲 (36BMP000020/MP20)Hager& Meisinger GmbH K233721KLS Martin 零钻式 MMF 螺釘KLS-Martin L.P.

官方來源

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