Clearance Summary
IRRIGATION TUBING SET 2.2M AND 3.8M received FDA 510(k) clearance under submission number K041124, sponsored by W&H Dentalwerk Burmoos. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-06-07.
- Submission: K041124
- Applicant / Sponsor: W&H Dentalwerk Burmoos
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2004-06-07
Classification & Regulation
This clearance is catalogued under FDA product code EBW and 21 CFR 872.4200, within the Dental review panel as a Class I device.