Miltex N-Tralig Intraligamentary Syringe
FDA 510(k) clearance K142414 · decided 2014-10-30
Clearance details
- K-number
- K142414
- Device name
- Miltex N-Tralig Intraligamentary Syringe
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-08-28
- Decision date
- 2014-10-30
- Days to decision
- 63 days
- Clearance type
- Special
- Product code
- EJI
- Device class
- 2
- Regulation number
- 872.6770
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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| DENJECTOR (K081694) | Dxm Co., Ltd. | 2008-09-12 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Fo (P810006/S114) | Integra LifeSciences Corporation | 2026-06-04 |
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| Helistat® Absorbable Collagen Hemostatic Agent (P850010/S117) | Integra LifeSciences Corporation | 2026-05-27 |
| Collastat Absorbable Collagen Hemostatic Sponge (P810006/S113) | Integra LifeSciences Corporation | 2026-05-27 |
| DuraSeal Exact Spine Sealant System (P080013/S030) | Integra LifeSciences Corporation | 2026-02-27 |
| DuraSeal Dural Sealant System (P040034/S041) | Integra LifeSciences Corporation | 2026-02-27 |
| DuraSeal Dural Sealant System (P040034/S040) | Integra LifeSciences Corporation | 2025-12-17 |
| DuraSeal Exact Spine Sealant System (P080013/S029) | Integra LifeSciences Corporation | 2025-12-17 |