Soft Tissue Augmentation Resorbable Matrix
FDA 510(k) clearance K233203 · decided 2024-05-01
Clearance details
- K-number
- K233203
- Device name
- Soft Tissue Augmentation Resorbable Matrix
- Applicant
- Collagen Matrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-28
- Decision date
- 2024-05-01
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- NPL
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Oakland, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.