Clearance Summary
HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST received FDA 510(k) clearance under submission number K003221, sponsored by Harald Nordin S.A. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-10-25.
- Submission: K003221
- Applicant / Sponsor: Harald Nordin S.A
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3810
- Decision date: 2000-10-25
Classification & Regulation
This clearance is catalogued under FDA product code ELR and 21 CFR 872.3810, within the Dental review panel as a Class I device.