Clearance Summary
SOLUSET CALCIUM DEMINERALIZING SOLUTION received FDA 510(k) clearance under submission number K864976, sponsored by Endo Technic Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1987-02-27.
- Submission: K864976
- Applicant / Sponsor: Endo Technic Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1987-02-27
Classification & Regulation
This clearance is catalogued under FDA product code EKS and 21 CFR 872.4565, within the Dental review panel as a Class I device.