Clearance Summary
CIMPAT N received FDA 510(k) clearance under submission number K972485, sponsored by Arent, Fox, Kintner, Plotkin & Kahn. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-09-08.
- Submission: K972485
- Applicant / Sponsor: Arent, Fox, Kintner, Plotkin & Kahn
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 1997-09-08
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.