The following data is part of a premarket notification filed by Luce Castle Co., Ltd. with the FDA for Luce Ceramic Bracket.
| Device ID | K201038 |
| 510k Number | K201038 |
| Device Name: | Luce Ceramic Bracket |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | Luce Castle Co., Ltd. 16, Ojeoncheon-ro, Uiwang Gyeonggi, KR |
| Contact | Kyung Joo Kim |
| Correspondent | Joyce Bang-kwon Provision Consulting Group Inc. 100 N. Barranca St Suite 700 West Covina, CA 91791 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-20 |
| Decision Date | 2020-10-09 |