Clearance Summary
EURO 45, ORDER-NO.: 2064 received FDA 510(k) clearance under submission number K012840, sponsored by Wieland Edelmetalle GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-10-23.
- Submission: K012840
- Applicant / Sponsor: Wieland Edelmetalle GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 2001-10-23
Classification & Regulation
This clearance is catalogued under FDA product code EJS and 21 CFR 872.3060, within the Dental review panel as a Class II device.