Device Classification Name |
Cleanser, Root Canal
|
510(k) Number |
K962743 |
Device Name |
PULPDENT SODIUM HYPOCHLORITE SOLUTION |
Applicant |
PULPDENT CORP. |
80 OAKLAND ST. |
WATERTOWN,
MA
02472
|
|
Applicant Contact |
KENNETH J BERK |
Correspondent |
PULPDENT CORP. |
80 OAKLAND ST. |
WATERTOWN,
MA
02472
|
|
Correspondent Contact |
KENNETH J BERK |
Classification Product Code |
|
Date Received | 07/15/1996 |
Decision Date | 08/06/1996 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|