Clearance Summary
CHIROPRO L SYSTEM received FDA 510(k) clearance under submission number K092214, sponsored by Bien-Air Dental, SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-12-15.
- Submission: K092214
- Applicant / Sponsor: Bien-Air Dental, SA
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2009-12-15
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.