The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Nexcomp And Meta Etchant.
| Device ID | K080305 |
| 510k Number | K080305 |
| Device Name: | NEXCOMP AND META ETCHANT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | META BIOMED CO., LTD. 414-12 MO CHOONG DONG CHEONG JU Cheung City, Chung Buk, KR 441-12 |
| Contact | Tae-hoon Kim |
| Correspondent | Tae-hoon Kim META BIOMED CO., LTD. 414-12 MO CHOONG DONG CHEONG JU Cheung City, Chung Buk, KR 441-12 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-05 |
| Decision Date | 2008-04-07 |
| Summary: | summary |