The following data is part of a premarket notification filed by Orthosun Co., Ltd. with the FDA for Mei Ceramic Bracket.
| Device ID | K190608 |
| 510k Number | K190608 |
| Device Name: | Mei Ceramic Bracket |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | Orthosun Co., Ltd. 2F, 112, Pyeongni-gil, Gyeyang-gu Incheon, KR 21008 |
| Contact | Ju-sung Lee |
| Correspondent | Peter Chung Plus Global 300 Atwood Street Pittsburgh, PA 15213 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-11 |
| Decision Date | 2019-11-04 |