Clearance Summary
UNICEM received FDA 510(k) clearance under submission number K094007, sponsored by 3M Espe AG 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 2010-04-08.
- Submission: K094007
- Applicant / Sponsor: 3M Espe AG Dental Products
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2010-04-08
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.