The following data is part of a premarket notification filed by Blackwell Device Consulting with the FDA for Polydimethylsiloxane Impression Material.
| Device ID | K131510 |
| 510k Number | K131510 |
| Device Name: | POLYDIMETHYLSILOXANE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | BLACKWELL DEVICE CONSULTING 104 2ND STREET SE Catawba, NC 28609 |
| Contact | Angela Blackwell |
| Correspondent | Angela Blackwell BLACKWELL DEVICE CONSULTING 104 2ND STREET SE Catawba, NC 28609 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-24 |
| Decision Date | 2013-12-20 |