FDA 510(k)

SprintRay 高影響力牙托基座

K 號：K221678 · 2022-11-10

決定日期2022-11-10

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

SprintRay High Impact Denture Base is the device name listed in this FDA 510(k) record. The listed applicant is Sprintray, Inc.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K221678. 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 SprintRay High Impact Denture Base?

SprintRay High Impact Denture Base is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Sprintray, Inc.. The 510(k) number is K221678.

When did SprintRay High Impact Denture Base receive FDA 510(k) clearance?

SprintRay High Impact Denture Base received FDA 510(k) clearance on 2022-11-10, under 510(k) number K221678.

Who is the listed applicant for SprintRay High Impact Denture Base?

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

What is the FDA product code for SprintRay High Impact Denture Base?

The FDA product code for SprintRay High Impact Denture Base is EBI.

其他以 Sprintray, Inc. 為申請人之記錄

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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.K262300假牙基座膠 V2Formlabs Ohio, Inc.K261474DENTCA 真柔軟Dentca, Inc.K260569DB 4000 高衝擊牙托基座Carbon, Inc.

官方來源

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