The following data is part of a premarket notification filed by Nanchang Dental Bright Technology Co., Ltd with the FDA for Dental Impression Material.
| Device ID | K211489 |
| 510k Number | K211489 |
| Device Name: | Dental Impression Material |
| Classification | Material, Impression |
| Applicant | Nanchang Dental Bright Technology Co., Ltd Building 182, Jiahai Industrial Park, No. 2799, Tianxiang Avenue, High-Tech Zone Nanchang, CN |
| Contact | Justin Qin |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-13 |
| Decision Date | 2021-07-28 |