Clearance Summary
CERAMIC PEDATRIC PREFORMED CROWN received FDA 510(k) clearance under submission number K091362, sponsored by Ez-Pedo, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-06-29.
- Submission: K091362
- Applicant / Sponsor: Ez-Pedo, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3330
- Decision date: 2009-06-29
Classification & Regulation
This clearance is catalogued under FDA product code ELZ and 21 CFR 872.3330, within the Dental review panel as a Class I device.