FDA 510(k)

Dentca Base Premium, Dentca Base Hi-Impact

K 號：K220042 · 2022-11-17

決定日期2022-11-17

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Dentca Base Premium, Dentca Base Hi-Impact is the device name listed in this FDA 510(k) record. The listed applicant is Dentca, Inc.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K220042. 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 Dentca Base Premium, Dentca Base Hi-Impact?

Dentca Base Premium, Dentca Base Hi-Impact is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Dentca, Inc.. The 510(k) number is K220042.

When did Dentca Base Premium, Dentca Base Hi-Impact receive FDA 510(k) clearance?

Dentca Base Premium, Dentca Base Hi-Impact received FDA 510(k) clearance on 2022-11-17, under 510(k) number K220042.

Who is the listed applicant for Dentca Base Premium, Dentca Base Hi-Impact?

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

What is the FDA product code for Dentca Base Premium, Dentca Base Hi-Impact?

The FDA product code for Dentca Base Premium, Dentca Base Hi-Impact is EBI.

其他以 Dentca, Inc. 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。

K261474DENTCA 真柔軟 K192806DENTCA 齒冠與橋梁 K172398DENTCA 牙托牙 K162044牙科假牙基座II

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。