The following data is part of a premarket notification filed by Mit Global Co., Ltd. with the FDA for Pre-milled Abutment.
| Device ID | K202269 |
| 510k Number | K202269 |
| Device Name: | PRE-MILLED Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | MIT Global Co., Ltd. 474 Dunchon-daero, Jungwon-gu Seongnam-si, KR 13229 |
| Contact | Lim Rok Won |
| Correspondent | Lim Rok Won MIT Global Co., Ltd. 474 Dunchon-daero, Jungwon-gu Seongnam-si, KR 13229 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-11 |
| Decision Date | 2020-11-25 |