Clearance Summary
SONIPLAK received FDA 510(k) clearance under submission number K935150, sponsored by American Dentronics, 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 1994-05-18.
- Submission: K935150
- Applicant / Sponsor: American Dentronics, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 1994-05-18
Classification & Regulation
This clearance is catalogued under FDA product code JEQ and 21 CFR 872.6865, within the Dental review panel as a Class I device.