Clearance Summary
DENTAL MATRIX BAND received FDA 510(k) clearance under submission number K071858, sponsored by Fly Cast Technologies, 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 2007-08-31.
- Submission: K071858
- Applicant / Sponsor: Fly Cast Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 2007-08-31
Classification & Regulation
This clearance is catalogued under FDA product code DZN and 21 CFR 872.4565, within the Dental review panel as a Class I device.