Clearance Summary
SDI POLYCARBONATE CROWN, SCHEIN'S received FDA 510(k) clearance under submission number K892893, sponsored by Svenska Dental Instruments AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-06-06.
- Submission: K892893
- Applicant / Sponsor: Svenska Dental Instruments AB
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3330
- Decision date: 1989-06-06
Classification & Regulation
This clearance is catalogued under FDA product code ELZ and 21 CFR 872.3330, within the Dental review panel as a Class I device.