Clearance Summary
EOS IMPRESSION TRAYS received FDA 510(k) clearance under submission number K896470, sponsored by Ivoclar North America, 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 1990-02-09.
- Submission: K896470
- Applicant / Sponsor: Ivoclar North America, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6880
- Decision date: 1990-02-09
Classification & Regulation
This clearance is catalogued under FDA product code EHY and 21 CFR 872.6880, within the Dental review panel as a Class I device.