Clearance Summary
JT-3 ELECTROGNATHOGRAPH received FDA 510(k) clearance under submission number K952218, sponsored by Bio-Research Associates, 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 1995-09-21.
- Submission: K952218
- Applicant / Sponsor: Bio-Research Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.2060
- Decision date: 1995-09-21
Classification & Regulation
This clearance is catalogued under FDA product code NFS and 21 CFR 872.2060, within the Dental review panel as a Class I device.