Clearance Summary
XENEX DENTAL ROULETTE received FDA 510(k) clearance under submission number K880485, sponsored by G & A Industries, 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 1988-05-02.
- Submission: K880485
- Applicant / Sponsor: G & A Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1988-05-02
Classification & Regulation
This clearance is catalogued under FDA product code EFW and 21 CFR 872.6855, within the Dental review panel as a Class I device.