Clearance Summary
DENTAL VACUUM INJECTION TRAY received FDA 510(k) clearance under submission number K904914, sponsored by The Lebanon Vac-Tray 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 1990-12-17.
- Submission: K904914
- Applicant / Sponsor: The Lebanon Vac-Tray Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6870
- Decision date: 1990-12-17
Classification & Regulation
This clearance is catalogued under FDA product code KMT and 21 CFR 872.6870, within the Dental review panel as a Class I device.