K250512
- 510(k) number
- K250512
- Device name
- Augmented Gingival Matrix
- Applicant
- Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. CN
- Product code
- NPL — Barrier, Animal Source, Intraoral
- Decision date
- 2025-12-05
- Date received
- 2025-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250512.pdf
Official FDA record: K250512
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.