Clearance Summary
COLTENE JET-MIXER received FDA 510(k) clearance under submission number K863998, sponsored by Coltene, 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 1986-10-30.
- Submission: K863998
- Applicant / Sponsor: Coltene, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1986-10-30
Classification & Regulation
This clearance is catalogued under FDA product code EID and 21 CFR 872.4565, within the Dental review panel as a Class I device.