The following data is part of a premarket notification filed by Hygedent Inc with the FDA for Hygedent Alginate Impression Material.
| Device ID | K140074 |
| 510k Number | K140074 |
| Device Name: | HYGEDENT ALGINATE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | HYGEDENT INC 7TH FLOOR,JINGUI BUSINESS BUILDING #982 CONGYUN RD, BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu HYGEDENT INC 7TH FLOOR,JINGUI BUSINESS BUILDING #982 CONGYUN RD, BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-13 |
| Decision Date | 2014-05-21 |
| Summary: | summary |