Clearance Summary
ORALVUE DENTAL MIRROR received FDA 510(k) clearance under submission number K946073, sponsored by Hines Group , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-02-16.
- Submission: K946073
- Applicant / Sponsor: Hines Group , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1995-02-16
Classification & Regulation
This clearance is catalogued under FDA product code EAX and 21 CFR 872.4565, within the Dental review panel as a Class I device.