Clearance Summary
DENTAL CLEANING RINGS received FDA 510(k) clearance under submission number K902325, sponsored by H. Bernath & Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1990-11-13.
- Submission: K902325
- Applicant / Sponsor: H. Bernath & Assoc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6390
- Decision date: 1990-11-13
Classification & Regulation
This clearance is catalogued under FDA product code JES and 21 CFR 872.6390, within the Dental review panel as a Class I device.