Device Classification Name |
Locator, Root Apex
|
510(k) Number |
K112508 |
Device Name |
I-ROOT 100 |
Applicant |
S-DENTI CO., LTD. |
VALLEY 6,481-4 |
GASAN-DONG GEUMCHEON-GU |
TAE KYE NAM,
KR
153-803
|
|
Applicant Contact |
TAE K NAM |
Correspondent |
S-DENTI CO., LTD. |
VALLEY 6,481-4 |
GASAN-DONG GEUMCHEON-GU |
TAE KYE NAM,
KR
153-803
|
|
Correspondent Contact |
TAE K NAM |
Classification Product Code |
|
Date Received | 08/30/2011 |
Decision Date | 06/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|