The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Metapaste Plus.
| Device ID | K210904 |
| 510k Number | K210904 |
| Device Name: | Metapaste Plus |
| Classification | Resin, Root Canal Filling |
| 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 | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-26 |
| Decision Date | 2021-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806387894858 | K210904 | 000 |
| 08806387894766 | K210904 | 000 |