Clearance Summary
AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE received FDA 510(k) clearance under submission number K020376, sponsored by Advanced Healthcare , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-04-09.
- Submission: K020376
- Applicant / Sponsor: Advanced Healthcare , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2002-04-09
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.