The following data is part of a premarket notification filed by World Bio Tech Co., Ltd with the FDA for Bijou Orthodontic Ceramic Bracket.
| Device ID | K152167 |
| 510k Number | K152167 |
| Device Name: | BIJOU Orthodontic Ceramic Bracket |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | WORLD BIO TECH CO., LTD #302 BIZCENTER, SKNTECHNOPARK, 124, SAGIMAKGOL-RO, JUNGWON-GU Seongnam-si, KR 462-721 |
| Contact | Jin-kyu Park |
| Correspondent | Peter Chung PLUS GLOBAL 300, ATWOOD Pittsburgh, PA 15213 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-04 |
| Decision Date | 2016-05-27 |
| Summary: | summary |