Clearance Summary
SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 received FDA 510(k) clearance under submission number K974487, sponsored by Asi Medical, 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 1998-02-18.
- Submission: K974487
- Applicant / Sponsor: Asi Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1998-02-18
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.