Clearance Summary
Augmented Gingival Matrix received FDA 510(k) clearance under submission number K250512, sponsored by Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-12-05.
- Submission: K250512
- Applicant / Sponsor: Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2025-12-05
Classification & Regulation
This clearance is catalogued under FDA product code NPL and 21 CFR 872.3930, within the Dental review panel as a Class II device.