Clearance Summary
TONGUE KLEAN received FDA 510(k) clearance under submission number K973175, sponsored by Softek Ent.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-10-14.
- Submission: K973175
- Applicant / Sponsor: Softek Ent.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1997-10-14
Classification & Regulation
This clearance is catalogued under FDA product code LCN and 21 CFR 872.6855, within the Dental review panel as a Class I device.