Clearance Summary
DENTAL ULTRASONIC SCALER INSERTS received FDA 510(k) clearance under submission number K953919, sponsored by Hu-Friedy Mfg. Co., 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 1995-10-07.
- Submission: K953919
- Applicant / Sponsor: Hu-Friedy Mfg. Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4850
- Decision date: 1995-10-07
Classification & Regulation
This clearance is catalogued under FDA product code ELC and 21 CFR 872.4850, within the Dental review panel as a Class II device.