Clearance Summary
TOUCH-N-HEAT MODEL 5001 received FDA 510(k) clearance under submission number K823486, sponsored by Analytic Technology. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1983-01-18.
- Submission: K823486
- Applicant / Sponsor: Analytic Technology
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3850
- Decision date: 1983-01-18
Classification & Regulation
This clearance is catalogued under FDA product code EKM and 21 CFR 872.3850, within the Dental review panel as a Class I device.