Clearance Summary
ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E received FDA 510(k) clearance under submission number K022821, sponsored by Ideatrics, 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 2002-11-15.
- Submission: K022821
- Applicant / Sponsor: Ideatrics, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4880
- Decision date: 2002-11-15
Classification & Regulation
This clearance is catalogued under FDA product code DZK and 21 CFR 872.4880, within the Dental review panel as a Class II device.