Clearance Summary
INCLUSIVE ZIRCONIA ABUTMENT BLANKS received FDA 510(k) clearance under submission number K083480, sponsored by Inclusive Dental Solutions. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-05-05.
- Submission: K083480
- Applicant / Sponsor: Inclusive Dental Solutions
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2009-05-05
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.