The following data is part of a premarket notification filed by Hygedent Inc. with the FDA for Hygeplus Alginate Impression Material.
| Device ID | K170812 |
| 510k Number | K170812 |
| Device Name: | HygePLUS Alginate Impression Material |
| Classification | Material, Impression |
| Applicant | HYGEDENT INC. Daliushu Industrial Zone Xiaotangshan Changping District 102211,Beijing Beijing, CN 102211 |
| Contact | Peng Wang |
| Correspondent | Peng Wang HYGEDENT INC. Daliushu Industrial Zone Xiaotangshan Changping District 102211,Beijing Beijing, CN 102211 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-17 |
| Decision Date | 2017-07-26 |
| Summary: | summary |