Clearance Summary
PRISM ZIRCONIA, ST-98 received FDA 510(k) clearance under submission number K141659, sponsored by A & D Dental Innovations. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-10-09.
- Submission: K141659
- Applicant / Sponsor: A & D Dental Innovations
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 2014-10-09
Classification & Regulation
This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.