The following data is part of a premarket notification filed by Millennium Dental International, Inc. with the FDA for Poly Siloxane Impression Material.
| Device ID | K053018 |
| 510k Number | K053018 |
| Device Name: | POLY SILOXANE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | MILLENNIUM DENTAL INTERNATIONAL, INC. 1980 HYDE PARK London, Ontario, CA N6h 5l9 |
| Contact | Jeanette Smith |
| Correspondent | Jeanette Smith MILLENNIUM DENTAL INTERNATIONAL, INC. 1980 HYDE PARK London, Ontario, CA N6h 5l9 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-26 |
| Decision Date | 2005-11-08 |