Clearance Summary
OTRES TOOTHBRUSH SANITIZER MODEL TB100W received FDA 510(k) clearance under submission number K003517, sponsored by Otres, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-06-06.
- Submission: K003517
- Applicant / Sponsor: Otres, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 2001-06-06
Classification & Regulation
This clearance is catalogued under FDA product code MCF and 21 CFR 872.6855, within the Dental review panel as a Class I device.