The following data is part of a premarket notification filed by Meta Biomed Co., Ltd with the FDA for Metacem.
| Device ID | K171449 |
| 510k Number | K171449 |
| Device Name: | Metacem |
| Classification | Cement, Dental |
| 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 2531 Pepperdale Drive Rowland Heights, CA 91748 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-17 |
| Decision Date | 2018-05-15 |
| Summary: | summary |