The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Et Hybrid Abutment.
| Device ID | K162390 |
| 510k Number | K162390 |
| Device Name: | ET Hybrid Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | HIOSSEN INC. 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Contact | David Kim |
| Correspondent | David Kim HIOSSEN INC. 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-26 |
| Decision Date | 2017-01-30 |
| Summary: | summary |