Device Classification Name |
locator, root apex
|
510(k) Number |
K112153 |
Device Name |
IROOT 100 MINI |
Applicant |
S-DENTI CO., LTD. |
300 ATWOOD |
PITTSBURGH,
PA
15213
|
|
Applicant Contact |
PETER CHUNG |
Correspondent |
S-DENTI CO., LTD. |
300 ATWOOD |
PITTSBURGH,
PA
15213
|
|
Correspondent Contact |
PETER CHUNG |
Classification Product Code |
|
Date Received | 07/07/2011 |
Decision Date | 04/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|