Clearance Summary
3181 DUO DELIVERY SYSTEM received FDA 510(k) clearance under submission number K000968, sponsored by A-Dec, 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 2000-05-03.
- Submission: K000968
- Applicant / Sponsor: A-Dec, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2000-05-03
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.