Clearance Summary
PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement received FDA 510(k) clearance under submission number K152652, sponsored by Gaia Dental Products, 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 2016-04-05.
- Submission: K152652
- Applicant / Sponsor: Gaia Dental Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2016-04-05
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.