Clearance Summary
PALATRAY LC RESIN IMPRESSION TRAY MATERIAL received FDA 510(k) clearance under submission number K902350, sponsored by Kulzer, 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 1990-07-26.
- Submission: K902350
- Applicant / Sponsor: Kulzer, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3670
- Decision date: 1990-07-26
Classification & Regulation
This clearance is catalogued under FDA product code EBH and 21 CFR 872.3670, within the Dental review panel as a Class I device.