Clearance Summary
HU-FRIEDY DENTAL CARTRIDGE SYRINGE received FDA 510(k) clearance under submission number K120659, sponsored by Hu-Friedy Mfg. Co., LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-11-06.
- Submission: K120659
- Applicant / Sponsor: Hu-Friedy Mfg. Co., LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6770
- Decision date: 2012-11-06
Classification & Regulation
This clearance is catalogued under FDA product code EJI and 21 CFR 872.6770, within the Dental review panel as a Class II device.