FDA 510(k)

Augmented Gingival Matrix

K-번호: K250512 · 2025-12-05

신청자Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.

결정일2025-12-05

제품 코드NPL

자문 위원회DE

결정Substantially Equivalent

기기 요약

Augmented Gingival Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K250512. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Augmented Gingival Matrix?

Augmented Gingival Matrix is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.. The 510(k) number is K250512.

When did Augmented Gingival Matrix receive FDA 510(k) clearance?

Augmented Gingival Matrix received FDA 510(k) clearance on 2025-12-05, under 510(k) number K250512.

Who is the listed applicant for Augmented Gingival Matrix?

The FDA 510(k) record lists Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Augmented Gingival Matrix?

The FDA product code for Augmented Gingival Matrix is NPL.

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Augmented Gingival Matrix

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: NPL)

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