Clearance Summary
CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676 received FDA 510(k) clearance under submission number K942198, sponsored by Rolence Enterprise Co. , 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 1994-05-27.
- Submission: K942198
- Applicant / Sponsor: Rolence Enterprise Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 1994-05-27
Classification & Regulation
This clearance is catalogued under FDA product code EBZ and 21 CFR 872.6070, within the Dental review panel as a Class II device.