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FDA 510(k)

Augmented Gingival Matrix

K-Number: K250512 · 2025-12-05

ApplicantNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
Decision Date2025-12-05
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Augmented Gingival Matrix?

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

When was Augmented Gingival Matrix approved by the FDA?

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

What company makes Augmented Gingival Matrix?

Augmented Gingival Matrix is manufactured by Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd..

What is the FDA product code for Augmented Gingival Matrix?

The FDA product code for Augmented Gingival Matrix is NPL.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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