Clearance Summary
PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS received FDA 510(k) clearance under submission number K130076, sponsored by Merz Dental GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2013-08-22.
- Submission: K130076
- Applicant / Sponsor: Merz Dental GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 2013-08-22
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.