Clearance Summary
ERCH ARCH BAR, MODEL 38-690-00 received FDA 510(k) clearance under submission number K061271, sponsored by KLS-Martin L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-06-30.
- Submission: K061271
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4600
- Decision date: 2006-06-30
Classification & Regulation
This clearance is catalogued under FDA product code DYX and 21 CFR 872.4600, within the Dental review panel as a Class II device.