The following data is part of a premarket notification filed by Shinhung Mst Co., Ltd. with the FDA for Luna Dental Implant System- Healing Abutment.
| Device ID | K200189 |
| 510k Number | K200189 |
| Device Name: | Luna Dental Implant System- Healing Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Shinhung MST Co., Ltd. 110-2, Donghwagong-Ro Munmak-Eup Wonju Si, KR 220-801 |
| Contact | Jae Soo Song |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, CA 92620 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-27 |
| Decision Date | 2020-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806343912787 | K200189 | 000 |
| 08806343911926 | K200189 | 000 |
| 08806343911919 | K200189 | 000 |
| 08806343911902 | K200189 | 000 |
| 08806343911896 | K200189 | 000 |
| 08806343911889 | K200189 | 000 |
| 08806343911872 | K200189 | 000 |
| 08806343908209 | K200189 | 000 |
| 08806343908193 | K200189 | 000 |
| 08806343908186 | K200189 | 000 |
| 08806343908179 | K200189 | 000 |
| 08806343908162 | K200189 | 000 |
| 08806343908155 | K200189 | 000 |
| 08806343908148 | K200189 | 000 |
| 08806343908131 | K200189 | 000 |
| 08806343908124 | K200189 | 000 |
| 08806343911933 | K200189 | 000 |
| 08806343911940 | K200189 | 000 |
| 08806343911957 | K200189 | 000 |
| 08806343912770 | K200189 | 000 |
| 08806343912763 | K200189 | 000 |
| 08806343912756 | K200189 | 000 |
| 08806343912749 | K200189 | 000 |
| 08806343912060 | K200189 | 000 |
| 08806343912053 | K200189 | 000 |
| 08806343912046 | K200189 | 000 |
| 08806343912039 | K200189 | 000 |
| 08806343912022 | K200189 | 000 |
| 08806343912015 | K200189 | 000 |
| 08806343912008 | K200189 | 000 |
| 08806343911995 | K200189 | 000 |
| 08806343911988 | K200189 | 000 |
| 08806343911971 | K200189 | 000 |
| 08806343911964 | K200189 | 000 |
| 08806343908117 | K200189 | 000 |