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 |