Clearance Summary
3M RelyX Pediatric Resin Modified Glass Ionomer Cement received FDA 510(k) clearance under submission number K191122, sponsored by 3M Espe Dental Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2019-05-29.
- Submission: K191122
- Applicant / Sponsor: 3M Espe Dental Products
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2019-05-29
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.