Cleared Traditional

Augmented Gingival Matrix

K250512 · Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. · Dental

Dec 2025

Decision

287d

Days

Class 2

Risk

About This 510(k) Submission

K250512 is an FDA 510(k) clearance for the Augmented Gingival Matrix, a Barrier, Animal Source, Intraoral (Class II — Special Controls, product code NPL), submitted by Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on December 5, 2025, 287 days after receiving the submission on February 21, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K250512 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 2025
Decision Date	December 05, 2025
Days to Decision	287 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NPL — Barrier, Animal Source, Intraoral
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants.