The following data is part of a premarket notification filed by Neobiotech Co., Ltd. with the FDA for S-mini Active Fixture.
| Device ID | K181178 |
| 510k Number | K181178 |
| Device Name: | S-mini Active Fixture |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Neobiotech Co., Ltd. #312-1, 36, Digital-ro 27-Gil, Guro-gu Seoul, KR 08381 |
| Contact | Young-ku Heo |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-02 |
| Decision Date | 2018-07-24 |
| Summary: | summary |