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 |