Clearance Summary
IMM DENTAL IRRIGATION TUBING SET received FDA 510(k) clearance under submission number K090727, sponsored by Innovative Medical Manufacturing Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-08-13.
- Submission: K090727
- Applicant / Sponsor: Innovative Medical Manufacturing Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2009-08-13
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.