Clearance Summary
ORTHODONTIC ELASTOMERIC SEPARATOR MODULE received FDA 510(k) clearance under submission number K943418, sponsored by Jon-Ko Products, 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 1995-05-23.
- Submission: K943418
- Applicant / Sponsor: Jon-Ko Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5410
- Decision date: 1995-05-23
Classification & Regulation
This clearance is catalogued under FDA product code ECI and 21 CFR 872.5410, within the Dental review panel as a Class I device.