Clearance Summary
COOL TEMP NATURAL received FDA 510(k) clearance under submission number K041098, sponsored by Coltene AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-05-13.
- Submission: K041098
- Applicant / Sponsor: Coltene AG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 2004-05-13
Classification & Regulation
This clearance is catalogued under FDA product code EBG and 21 CFR 872.3770, within the Dental review panel as a Class II device.