Clearance Summary
PORTALLOY 54 received FDA 510(k) clearance under submission number K021242, sponsored by Wieland Dental + Technik GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-05-16.
- Submission: K021242
- Applicant / Sponsor: Wieland Dental + Technik GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3060
- Decision date: 2002-05-16
Classification & Regulation
This clearance is catalogued under FDA product code EJT and 21 CFR 872.3060, within the Dental review panel as a Class II device.