The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Metacem, Meta P&bond, Metacem Silane Ceramic Primer.
| Device ID | K081913 |
| 510k Number | K081913 |
| Device Name: | METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER |
| Classification | Cement, Dental |
| Applicant | META BIOMED CO., LTD. 414-12 MO CHOONG DONG Cheung Ju City, Chung Buk, KR 441-12 |
| Contact | Tae-hoon Kim |
| Correspondent | Tae-hoon Kim META BIOMED CO., LTD. 414-12 MO CHOONG DONG Cheung Ju City, Chung Buk, KR 441-12 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-03 |
| Decision Date | 2008-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806387892212 | K081913 | 000 |
| 08806387892205 | K081913 | 000 |
| 08806387892199 | K081913 | 000 |
| 08806387892182 | K081913 | 000 |
| 08806387892175 | K081913 | 000 |
| 08806387892168 | K081913 | 000 |
| 08806387892151 | K081913 | 000 |