The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Nexcomp.
| Device ID | K181689 |
| 510k Number | K181689 |
| Device Name: | Nexcomp |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Meta Biomed Co., Ltd. 270, Osong Saengmyeong 1-ro, Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
| Contact | Suk Song Oh |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-26 |
| Decision Date | 2018-11-15 |