Device Classification Name |
cleanser, root canal
|
510(k) Number |
K072555 |
Device Name |
EDTA PLUS |
Applicant |
ESSENTIAL DENTAL SYSTEMS, INC. |
89 LEUNING ST. |
SUITE 8 |
SOUTH HACKENSACK,
NJ
07606
|
|
Applicant Contact |
BRIAN RASIMICK |
Correspondent |
ESSENTIAL DENTAL SYSTEMS, INC. |
89 LEUNING ST. |
SUITE 8 |
SOUTH HACKENSACK,
NJ
07606
|
|
Correspondent Contact |
BRIAN RASIMICK |
Classification Product Code |
|
Date Received | 09/10/2007 |
Decision Date | 12/13/2007 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|