The following data is part of a premarket notification filed by Northeast Resins & Silicones, Llc. with the FDA for Silicone Impression Material.
| Device ID | K011450 |
| 510k Number | K011450 |
| Device Name: | SILICONE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | NORTHEAST RESINS & SILICONES, LLC. 698 ANDREA CT Cheshire, CT 06410 |
| Contact | Sivananda S Jada |
| Correspondent | Sivananda S Jada NORTHEAST RESINS & SILICONES, LLC. 698 ANDREA CT Cheshire, CT 06410 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-11 |
| Decision Date | 2001-06-13 |