Clearance Summary
MINIBLASTER received FDA 510(k) clearance under submission number K013969, sponsored by Deldent , 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 2002-01-10.
- Submission: K013969
- Applicant / Sponsor: Deldent , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6080
- Decision date: 2002-01-10
Classification & Regulation
This clearance is catalogued under FDA product code KOJ and 21 CFR 872.6080, within the Dental review panel as a Class II device.