S1
FDA 510(k) clearance K231672 · decided 2023-10-13
Clearance details
- K-number
- K231672
- Device name
- S1
- Applicant
- Medpark Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-06-08
- Decision date
- 2023-10-13
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- NPM
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Buk-Gu, KR
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| BOSS (K253723) | Medpark Co., Ltd. | 2026-06-16 |
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| SwissGraft X (K251613) | Geistlich Pharma AG | 2025-06-26 |
| Geistlich Bio-Flow® (K242510) | Geistlich Pharma AG | 2025-03-07 |
| Xenograft Bovine Bone Particulate (K240133) | Collagen Solutions, LLC | 2024-08-16 |
| THE Graft Collagen (K230305) | Purgo Biologics, Inc. | 2024-07-24 |
| Geistlich Bio-Oss® (K240661) | Geistlich Pharma AG | 2024-07-12 |
| InterOss Collagen (K221808) | Sigmagraft, Inc. | 2023-03-18 |
| Wishbone HA (K211551) | Wishbone SA | 2021-08-20 |
| Porcine Mineral Collagen Composite (K202183) | Collagen Matrix, Inc. | 2021-04-02 |
| Porcine Mineral Collagen Composite Moldable (K201859) | Collagen Matrix, Inc. | 2020-09-11 |
| DSM Biomedical Dental Bone Graft Plus (K193212) | Dsm Biomedical | 2020-09-10 |
Recalls involving this device
No recalls on record reference this clearance.