Clearance Summary
ULTRACEM received FDA 510(k) clearance under submission number K132255, sponsored by Ultradent Products Inc. / Oratech, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2013-10-24.
- Submission: K132255
- Applicant / Sponsor: Ultradent Products Inc. / Oratech, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2013-10-24
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.