Clearance Summary
NUPRO* GEL TRAY received FDA 510(k) clearance under submission number K820104, sponsored by Johnson & Johnson Professionals, 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 1982-02-23.
- Submission: K820104
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6870
- Decision date: 1982-02-23
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.