The following data is part of a premarket notification filed by Ht Co., Ltd. with the FDA for Orthodontic Ceramic Bracket.
| Device ID | K102561 |
| 510k Number | K102561 |
| Device Name: | ORTHODONTIC CERAMIC BRACKET |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | HT CO., LTD. HBI 527, HANYANG UNIV. 1271 SA 1(IL)-DONG SANGNOK-GU Ansan-si, Gyeonggi-do, KR 426-791 |
| Contact | Jerry Choi |
| Correspondent | Jerry Choi HT CO., LTD. HBI 527, HANYANG UNIV. 1271 SA 1(IL)-DONG SANGNOK-GU Ansan-si, Gyeonggi-do, KR 426-791 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-07 |
| Decision Date | 2011-01-25 |
| Summary: | summary |