Clearance Summary
APROXI 1100 AND 4000 SERIES DENTAL INLAYS received FDA 510(k) clearance under submission number K073047, sponsored by Aproxi Aps. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-08-07.
- Submission: K073047
- Applicant / Sponsor: Aproxi Aps
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2008-08-07
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.