FDA 510(k)

InRoad® Dental Synthetic Bone Graft

K-번호: K202675 · 2022-03-04

결정일2022-03-04

제품 코드LYC

자문 위원회DE

결정Substantially Equivalent

기기 요약

InRoad® Dental Synthetic Bone Graft is the device name listed in this FDA 510(k) record. The listed applicant is Osteogene Tech Corp. It received FDA 510(k) clearance on 2022-03-04 under 510(k) number K202675. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the InRoad® Dental Synthetic Bone Graft?

InRoad® Dental Synthetic Bone Graft is a medical device that received FDA 510(k) clearance on 2022-03-04. The listed applicant is Osteogene Tech Corp. The 510(k) number is K202675.

When did InRoad® Dental Synthetic Bone Graft receive FDA 510(k) clearance?

InRoad® Dental Synthetic Bone Graft received FDA 510(k) clearance on 2022-03-04, under 510(k) number K202675.

Who is the listed applicant for InRoad® Dental Synthetic Bone Graft?

The FDA 510(k) record lists Osteogene Tech Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InRoad® Dental Synthetic Bone Graft?

The FDA product code for InRoad® Dental Synthetic Bone Graft is LYC.

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InRoad® Dental Synthetic Bone Graft

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LYC)

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