Augmented Gingival Matrix
FDA 510(k) clearance K250512 · decided 2025-12-05
Clearance details
- K-number
- K250512
- Device name
- Augmented Gingival Matrix
- Applicant
- Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-21
- Decision date
- 2025-12-05
- Days to decision
- 287 days
- Clearance type
- Traditional
- Product code
- NPL
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Suzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.