Device Classification Name |
Bracket, Ceramic, Orthodontic
|
510(k) Number |
K150141 |
Device Name |
Orthodontics Bracket |
Applicant |
Speed Dental Co., Ltd. |
#203-1, A-dong, Posco the Sharp, 151 Sunhwa-dong, Jung-gu |
Seoul,
KR
100-130
|
|
Applicant Contact |
Tae Young Kang |
Correspondent |
Onbix Corporation |
#821 Samil Plaza, 837-26 Yeuksam-dong |
Gangnam-gu,
KR
135-768
|
|
Correspondent Contact |
Ho Dong Yang |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 01/22/2015 |
Decision Date | 10/23/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|