Clearance Summary
OMNI-MATRIX received FDA 510(k) clearance under submission number K930151, sponsored by Innovative Technology , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1993-09-23.
- Submission: K930151
- Applicant / Sponsor: Innovative Technology , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1993-09-23
Classification & Regulation
This clearance is catalogued under FDA product code JEP and 21 CFR 872.4565, within the Dental review panel as a Class I device.