FDA 510(k)

KDG 牙槽橋

K 號：K221381 · 2022-08-10

決定日期2022-08-10

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

KDG Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Dental, Inc.. It received FDA 510(k) clearance on 2022-08-10 under 510(k) number K221381. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KDG Abutments?

KDG Abutments is a medical device that received FDA 510(k) clearance on 2022-08-10. The listed applicant is Keystone Dental, Inc.. The 510(k) number is K221381.

When did KDG Abutments receive FDA 510(k) clearance?

KDG Abutments received FDA 510(k) clearance on 2022-08-10, under 510(k) number K221381.

Who is the listed applicant for KDG Abutments?

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

What is the FDA product code for KDG Abutments?

The FDA product code for KDG Abutments is NHA.

其他以 Keystone Dental, Inc. 為申請人之記錄

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官方來源

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