Clearance Summary
NEY EQUI-HINGE received FDA 510(k) clearance under submission number K790290, sponsored by Deringer-Ney, 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 1979-04-10.
- Submission: K790290
- Applicant / Sponsor: Deringer-Ney, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6710
- Decision date: 1979-04-10
Classification & Regulation
This clearance is catalogued under FDA product code ECG and 21 CFR 872.6710, within the Dental review panel as a Class I device.