The following data is part of a premarket notification filed by Shinhung Mst Co., Ltd with the FDA for Luna Dental Implant System.
| Device ID | K160106 |
| 510k Number | K160106 |
| Device Name: | LUNA DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SHINHUNG MST Co., Ltd 110-2, Donghwagongdan-Ro, Munmak-Eup Wonju-si, KR 220-801 |
| Contact | Sunbyung Lee |
| Correspondent | Sunbyung Lee SHINHUNG MST Co., Ltd 110-2, Donghwagongdan-Ro, Munmak-Eup Wonju-si, KR 220-801 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2016-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809458319943 | K160106 | 000 |
| 18809458319844 | K160106 | 000 |
| 18809458319851 | K160106 | 000 |
| 18809458319868 | K160106 | 000 |
| 18809458319875 | K160106 | 000 |
| 18809458319882 | K160106 | 000 |
| 18809458319899 | K160106 | 000 |
| 18809458319905 | K160106 | 000 |
| 18809458319912 | K160106 | 000 |
| 18809458319929 | K160106 | 000 |
| 18809458319936 | K160106 | 000 |
| 18809458319837 | K160106 | 000 |