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 |