FDA 510(k)

Perfit FS 齿科全烧结氧化鋁礦塊

K 號：K222686 · 2022-10-06

決定日期2022-10-06

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Perfit FS Dental Zirconia Fully Sintered Block is the device name listed in this FDA 510(k) record. The listed applicant is Vatech Acucera, Inc.. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K222686. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Perfit FS Dental Zirconia Fully Sintered Block?

Perfit FS Dental Zirconia Fully Sintered Block is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Vatech Acucera, Inc.. The 510(k) number is K222686.

When did Perfit FS Dental Zirconia Fully Sintered Block receive FDA 510(k) clearance?

Perfit FS Dental Zirconia Fully Sintered Block received FDA 510(k) clearance on 2022-10-06, under 510(k) number K222686.

Who is the listed applicant for Perfit FS Dental Zirconia Fully Sintered Block?

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

What is the FDA product code for Perfit FS Dental Zirconia Fully Sintered Block?

The FDA product code for Perfit FS Dental Zirconia Fully Sintered Block is EIH.

其他以 Vatech Acucera, 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。

K203590Perfit FS 齿科全烧结氧化鋁礦塊 K203499Perfit ZR ST 齒科氧化鋁礦空白，Perfit ZR UT 齒科氧化鋁礦空白 K203351Perfit ZR HT 齿科氧化鋁陶瓷空白

相關器械（代碼：EIH）

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。

K262074任何-錫科斯Mediclus Co., Ltd.K262239Obsidian® 压克力壓克力超過鎂鋁Prismatik Dentalcraft, Inc.K261046牙醫用氧化鋁陶瓷空白片及上色液Hunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy陶瓷染色及釉料Zima International Inc., dba Dandy K260918佐立隆尼士Amann Girrbach AG K260859羅塞塔SM，羅塞塔SPHass Corp.

官方來源

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