The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Et Hybrid Abutment.
| Device ID | K170421 |
| 510k Number | K170421 |
| 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 | 2017-02-13 |
| Decision Date | 2018-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814913024844 | K170421 | 000 |
| 00814913024837 | K170421 | 000 |
| 00814913024820 | K170421 | 000 |
| 00814913024813 | K170421 | 000 |