Device Classification Name |
implant, endosseous, orthodontic
|
510(k) Number |
K161335 |
Device Name |
Dual Top Screw System |
Applicant |
JEIL MEDICAL CORPORATION |
702, 703, 704, 705, 706, 804, 805, 807, 812-HO, 55, |
DIGITAL-RO34-GIL, GURO-GU |
SEOUL,
KR
08378
|
|
Applicant Contact |
SEUNGYOUNG LEE |
Correspondent |
JEIL MEDICAL CORPORATION |
702, 703, 704, 705, 706, 804, 805, 807, 812-HO, 55, |
DIGITAL-RO34-GIL, GURO-GU |
SEOUL,
KR
08378
|
|
Correspondent Contact |
SEUNGYOUNG LEE |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 05/12/2016 |
Decision Date | 02/23/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|