Clearance Summary
SMYLON (DENTAL STAIN ERASER) received FDA 510(k) clearance under submission number K891338, sponsored by The Smylon Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-11-14.
- Submission: K891338
- Applicant / Sponsor: The Smylon Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1989-11-14
Classification & Regulation
This clearance is catalogued under FDA product code MAU and 21 CFR 872.6855, within the Dental review panel as a Class I device.