CeraSeal
Resin, Root Canal Filling
Meta Biomed Co., Ltd.
The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Ceraseal.
Pre-market Notification Details
| Device ID | K190503 |
| 510k Number | K190503 |
| Device Name: | CeraSeal |
| 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 | 2019-03-01 |
| Decision Date | 2019-06-07 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806387894124 | K190503 | 000 |
| 08806387894841 | K190503 | 000 |
| 08806387894810 | K190503 | 000 |
| 08806387860037 | K190503 | 000 |
Trademark Results [CeraSeal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERASEAL 79292826 not registered Live/Pending |
META BIOMED CO., LTD. 2020-07-29 |
 CERASEAL 77008131 not registered Dead/Abandoned |
Kingston Brass Inc 2006-09-26 |
 CERASEAL 72230748 0827492 Dead/Expired |
AEROVOX CORPORATION 1965-10-21 |
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