FDA 510(k)

Proximerge 2 Dental Implant System

K-번호: K211409 · 2022-10-19

결정일2022-10-19

제품 코드DZE

자문 위원회DE

결정Substantially Equivalent

기기 요약

Proximerge 2 Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Quadric Biomed, LLC. It received FDA 510(k) clearance on 2022-10-19 under 510(k) number K211409. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Proximerge 2 Dental Implant System?

Proximerge 2 Dental Implant System is a medical device that received FDA 510(k) clearance on 2022-10-19. The listed applicant is Quadric Biomed, LLC. The 510(k) number is K211409.

When did Proximerge 2 Dental Implant System receive FDA 510(k) clearance?

Proximerge 2 Dental Implant System received FDA 510(k) clearance on 2022-10-19, under 510(k) number K211409.

Who is the listed applicant for Proximerge 2 Dental Implant System?

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

What is the FDA product code for Proximerge 2 Dental Implant System?

The FDA product code for Proximerge 2 Dental Implant System is DZE.

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Proximerge 2 Dental Implant System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: DZE)

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