Clearance Summary
ZAP DUAL CURING LIGHT received FDA 510(k) clearance under submission number K002991, sponsored by Soft-Core Texas, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-11-28.
- Submission: K002991
- Applicant / Sponsor: Soft-Core Texas, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 2000-11-28
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.