FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Augmented Gingival Matrix
K Number: K250512
·
Decision Dec 5, 2025
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
56
Applicant Total
1
Review Days
287
Basic Information
- Device Name
- Augmented Gingival Matrix
- K Number
- K250512
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
- Date Received
- February 21, 2025
- Decision Date
- December 5, 2025
- Product Code
- NPL
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | FDA class 2 | Dental |
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