Clearance Summary
DYNA IMPLANT DESIGN received FDA 510(k) clearance under submission number K930868, sponsored by Dyna Dental Engineering BV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-04-28.
- Submission: K930868
- Applicant / Sponsor: Dyna Dental Engineering BV
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1995-04-28
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.