Clearance Summary
MASKY received FDA 510(k) clearance under submission number K973542, sponsored by Pressing DI Monticelli Rag. Stefano. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-02-10.
- Submission: K973542
- Applicant / Sponsor: Pressing DI Monticelli Rag. Stefano
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 1998-02-10
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.