Clearance Summary
ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE received FDA 510(k) clearance under submission number K002168, sponsored by Ronvig Instruments, Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-10-13.
- Submission: K002168
- Applicant / Sponsor: Ronvig Instruments, Ltd.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6770
- Decision date: 2000-10-13
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.