Clearance Summary
TWIXEL(TM) received FDA 510(k) clearance under submission number K885056, sponsored by Fouts Development, 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 1989-01-04.
- Submission: K885056
- Applicant / Sponsor: Fouts Development, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6390
- Decision date: 1989-01-04
Classification & Regulation
This clearance is catalogued under FDA product code JES and 21 CFR 872.6390, within the Dental review panel as a Class I device.