Clearance Summary
DENTEK EASY BRUSH WITH FLUORIDE received FDA 510(k) clearance under submission number K130186, sponsored by Den Tek Oral Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2013-07-15.
- Submission: K130186
- Applicant / Sponsor: Den Tek Oral Care, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 2013-07-15
Classification & Regulation
This clearance is catalogued under FDA product code EFW and 21 CFR 872.6855, within the Dental review panel as a Class I device.