Clearance Summary
SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 received FDA 510(k) clearance under submission number K022959, sponsored by MDC Research , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-02-05.
- Submission: K022959
- Applicant / Sponsor: MDC Research , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6770
- Decision date: 2003-02-05
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.