Clearance Summary
OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND received FDA 510(k) clearance under submission number K011769, sponsored by Opusdent , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2001-08-30.
- Submission: K011769
- Applicant / Sponsor: Opusdent , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2001-08-30
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.