FDA 510(k)

ATLANTIS ISUS Implant Suprastructures

K 號：K160207 · 2016-09-21

決定日期2016-09-21

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

ATLANTIS ISUS Implant Suprastructures is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International, Inc.. It received FDA 510(k) clearance on 2016-09-21 under 510(k) number K160207. 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 ATLANTIS ISUS Implant Suprastructures?

ATLANTIS ISUS Implant Suprastructures is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Dentsply International, Inc.. The 510(k) number is K160207.

When did ATLANTIS ISUS Implant Suprastructures receive FDA 510(k) clearance?

ATLANTIS ISUS Implant Suprastructures received FDA 510(k) clearance on 2016-09-21, under 510(k) number K160207.

Who is the listed applicant for ATLANTIS ISUS Implant Suprastructures?

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

What is the FDA product code for ATLANTIS ISUS Implant Suprastructures?

The FDA product code for ATLANTIS ISUS Implant Suprastructures is NHA.

其他以 Dentsply International, Inc. 為申請人之記錄

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