Clearance Summary
ECO/DENTAL GENERAL DENTAL PACK received FDA 510(k) clearance under submission number K922988, sponsored by Dyna-Pace Systems, 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 1992-11-04.
- Submission: K922988
- Applicant / Sponsor: Dyna-Pace Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1992-11-04
Classification & Regulation
This clearance is catalogued under FDA product code EKJ and 21 CFR 872.4565, within the Dental review panel as a Class I device.