Clearance Summary
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel received FDA 510(k) clearance under submission number K172977, sponsored by Nanova Biomaterials, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-01-16.
- Submission: K172977
- Applicant / Sponsor: Nanova Biomaterials, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 2018-01-16
Classification & Regulation
This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.