Clearance Summary
Regenomer® Syringe, Regenomer® Plug, Regenomer® Block received FDA 510(k) clearance under submission number K150079, sponsored by Nibec Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2015-12-10.
- Submission: K150079
- Applicant / Sponsor: Nibec Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2015-12-10
Classification & Regulation
This clearance is catalogued under FDA product code NPM and 21 CFR 872.3930, within the Dental review panel as a Class II device.