Clearance Summary
DE-BOND 200 received FDA 510(k) clearance under submission number K883418, sponsored by Scheu-Dental. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-10-24.
- Submission: K883418
- Applicant / Sponsor: Scheu-Dental
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1989-10-24
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.