Clearance Summary
IROOT BP, MODEL IRBP 4609 received FDA 510(k) clearance under submission number K082943, sponsored by Innovative Bioceramix, 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 2009-01-06.
- Submission: K082943
- Applicant / Sponsor: Innovative Bioceramix, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3820
- Decision date: 2009-01-06
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.