Device Classification Name |
cleanser, root canal
|
510(k) Number |
K070401 |
Device Name |
ENDO-CHX |
Applicant |
ESSENTIAL DENTAL SYSTEMS, INC. |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN GOLDSTEIN-FALK |
Correspondent |
ESSENTIAL DENTAL SYSTEMS, INC. |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN GOLDSTEIN-FALK |
Classification Product Code |
|
Date Received | 02/12/2007 |
Decision Date | 07/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|