Clearance Summary
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus received FDA 510(k) clearance under submission number K250473, sponsored by Dci International, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-02-19.
- Submission: K250473
- Applicant / Sponsor: Dci International, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2025-02-19
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.