Clearance Summary
R-SI-LINE METAL-BITE received FDA 510(k) clearance under submission number K010926, sponsored by R-Dental Dentalerzeugnisse 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 2001-04-12.
- Submission: K010926
- Applicant / Sponsor: R-Dental Dentalerzeugnisse GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2001-04-12
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.