The following data is part of a premarket notification filed by Danville Materials Llc with the FDA for Star+ Vps Scannable Impression Material.
| Device ID | K152349 |
| 510k Number | K152349 |
| Device Name: | Star+ VPS Scannable Impression Material |
| Classification | Material, Impression |
| Applicant | DANVILLE MATERIALS LLC 3420 FOSTORIA WAY SUITE A-200 San Ramon, CA 94583 |
| Contact | Dong Hua |
| Correspondent | Dong Hua DANVILLE MATERIALS LLC 3420 FOSTORIA WAY SUITE A-200 San Ramon, CA 94583 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-20 |
| Decision Date | 2015-11-23 |