The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Hg Iii Fixture System.
| Device ID | K093352 |
| 510k Number | K093352 |
| Device Name: | HG III FIXTURE SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | HIOSSEN INC. 85 BEN FAIRLESS DRIVE Fairless Hills, PA 19030 |
| Contact | Patrick Lim |
| Correspondent | Patrick Lim HIOSSEN INC. 85 BEN FAIRLESS DRIVE Fairless Hills, PA 19030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-27 |
| Decision Date | 2009-11-24 |
| Summary: | summary |