The following data is part of a premarket notification filed by Biocetec Co., Ltd with the FDA for C-line Orthodontic Ceramic Bracket.
Device ID | K163467 |
510k Number | K163467 |
Device Name: | C-Line Orthodontic Ceramic Bracket |
Classification | Bracket, Ceramic, Orthodontic |
Applicant | BIOCETEC CO., LTD RM 3-952AB, H1-DONG, KIST,5, HWARANG-RO 14-GIL (HAWOLGOK-DONG 39-1) Seoul, KR |
Contact | Dave Kim |
Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
Product Code | NJM |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-12 |
Decision Date | 2017-06-14 |
Summary: | summary |