Clearance Summary
SILICONE IMPRESSION MATERIAL received FDA 510(k) clearance under submission number K011450, sponsored by Northeast Resins & Silicones, 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 2001-06-13.
- Submission: K011450
- Applicant / Sponsor: Northeast Resins & Silicones, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 2001-06-13
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.