Clearance Summary
GUTTAFLOW received FDA 510(k) clearance under submission number K032662, sponsored by Coltene/Whaledent GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-11-03.
- Submission: K032662
- Applicant / Sponsor: Coltene/Whaledent GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3820
- Decision date: 2003-11-03
Classification & Regulation
This clearance is catalogued under FDA product code KIF and 21 CFR 872.3820, within the Dental review panel as a Class II device.