Clearance Summary
Miltex N-Tralig Intraligamentary Syringe received FDA 510(k) clearance under submission number K142414, sponsored by Integra LifeSciences Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-10-30.
- Submission: K142414
- Applicant / Sponsor: Integra LifeSciences Corporation
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6770
- Decision date: 2014-10-30
Classification & Regulation
This clearance is catalogued under FDA product code EJI and 21 CFR 872.6770, within the Dental review panel as a Class II device.