Clearance Summary
SPACELINE FEEL 21 received FDA 510(k) clearance under submission number K953865, sponsored by J. Morita USA, 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 1996-03-20.
- Submission: K953865
- Applicant / Sponsor: J. Morita USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1996-03-20
Classification & Regulation
This clearance is catalogued under FDA product code EFA and 21 CFR 872.4200, within the Dental review panel as a Class I device.