The following data is part of a premarket notification filed by Speed Dental Co., Ltd. with the FDA for Orthodontics Bracket.
| Device ID | K150141 |
| 510k Number | K150141 |
| Device Name: | Orthodontics Bracket |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | Speed Dental Co., Ltd. #203-1, A-dong, Posco The Sharp, 151 Sunhwa-dong, Jung-gu Seoul, KR 100-130 |
| Contact | Tae Young Kang |
| Correspondent | Ho Dong Yang Onbix Corporation #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, KR 135-768 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-22 |
| Decision Date | 2015-10-23 |
| Summary: | summary |