Clearance Summary
FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 received FDA 510(k) clearance under submission number K080249, sponsored by Ultradent Products, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-02-08.
- Submission: K080249
- Applicant / Sponsor: Ultradent Products, Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3260
- Decision date: 2008-02-08
Classification & Regulation
This clearance is catalogued under FDA product code LBH and 21 CFR 872.3260, within the Dental review panel as a Class II device.