FDA 510(k)

假牙基座膠 V2

K 號：K262300 · 2026-07-08

決定日期2026-07-08

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Denture Base Resin V2 is the device name listed in this FDA 510(k) record. The listed applicant is Formlabs Ohio, Inc.. It received FDA 510(k) clearance on 2026-07-08 under 510(k) number K262300. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Denture Base Resin V2?

Denture Base Resin V2 is a medical device that received FDA 510(k) clearance on 2026-07-08. The listed applicant is Formlabs Ohio, Inc.. The 510(k) number is K262300.

When did Denture Base Resin V2 receive FDA 510(k) clearance?

Denture Base Resin V2 received FDA 510(k) clearance on 2026-07-08, under 510(k) number K262300.

Who is the listed applicant for Denture Base Resin V2?

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

What is the FDA product code for Denture Base Resin V2?

The FDA product code for Denture Base Resin V2 is EBI.

其他以 Formlabs Ohio, Inc. 為申請人之記錄

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K240538優質牙齒树脂 K232087牙科LT舒適树脂 K222061牙科LT清晰V2膠

相關器械（代碼：EBI）

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。

K261802Glidewell™ 牙托基材膠Prismatik Dentalcraft, Inc.K261626超印柔軟假牙紫外線Guangzhou Heygears IMC., Inc.K262681奈米瓷膠膠黏劑3BFAB TEKNOLOJI A.S.K261474DENTCA 真柔軟Dentca, Inc.K260569DB 4000 高衝擊牙托基座Carbon, Inc.K260376假牙基座Shandong Huge Dental Material Corporation

官方來源

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