Clearance Summary
MD 10, SEM, SM 12, CBM received FDA 510(k) clearance under submission number K000710, sponsored by NOUVAG AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-05-11.
- Submission: K000710
- Applicant / Sponsor: NOUVAG AG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2000-05-11
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.