Device Classification Name |
cleanser, root canal
|
510(k) Number |
K140846 |
Device Name |
EDS COMBO-RINSE |
Applicant |
ESSENTIAL DENTAL SYSTEMS, INC. |
89 LEUNING STREET |
SUITE 8 |
SOUTH HACKENSACK,
NJ
07606
|
|
Applicant Contact |
JEFFREY WAN |
Correspondent |
ESSENTIAL DENTAL SYSTEMS, INC. |
89 LEUNING STREET |
SUITE 8 |
SOUTH HACKENSACK,
NJ
07606
|
|
Correspondent Contact |
JEFFREY WAN |
Classification Product Code |
|
Date Received | 04/03/2014 |
Decision Date | 07/25/2014 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|