Clearance Summary
CHEW-DENT received FDA 510(k) clearance under submission number K843406, sponsored by Senair-Mot. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1984-12-11.
- Submission: K843406
- Applicant / Sponsor: Senair-Mot
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6650
- Decision date: 1984-12-11
Classification & Regulation
This clearance is catalogued under FDA product code JEW and 21 CFR 872.6650, within the Dental review panel as a Class I device.