The following data is part of a premarket notification filed by Hygedent Inc. with the FDA for Vps Impression Material.
| Device ID | K191034 |
| 510k Number | K191034 |
| Device Name: | VPS Impression Material |
| Classification | Material, Impression |
| Applicant | Hygedent Inc. Room 210C, Building 4, No 5 Chaoqian Road, Science Industry Park, Changping Beijing, CN 102299 |
| Contact | Peng Wang |
| Correspondent | Peng Wang Hygedent Inc. Room 210C, Building 4, No 5 Chaoqian Road, Science Industry Park, Changping Beijing, CN 102299 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-18 |
| Decision Date | 2019-09-04 |
| Summary: | summary |