Clearance Summary
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM received FDA 510(k) clearance under submission number K122955, sponsored by Wright Health Group , 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 2013-03-01.
- Submission: K122955
- Applicant / Sponsor: Wright Health Group , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3590
- Decision date: 2013-03-01
Classification & Regulation
This clearance is catalogued under FDA product code ELM and 21 CFR 872.3590, within the Dental review panel as a Class II device.