Clearance Summary
GEBDI TRIBOS 501 received FDA 510(k) clearance under submission number K092231, sponsored by Gebdi Dental-Products 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 2009-11-24.
- Submission: K092231
- Applicant / Sponsor: Gebdi Dental-Products GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3590
- Decision date: 2009-11-24
Classification & Regulation
This clearance is catalogued under FDA product code ELM and 21 CFR 872.3590, within the Dental review panel as a Class II device.