Device Classification Name |
Cleanser, Root Canal
|
510(k) Number |
K103244 |
Device Name |
QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION |
Applicant |
DENTSPLY INTL., INC. |
SUSQUEHANNA COMMERCE CENTER |
221 W PHILADELPHIA ST. STE 60 |
YORK,
PA
17404
|
|
Applicant Contact |
HELEN LEWIS |
Correspondent |
DENTSPLY INTL., INC. |
SUSQUEHANNA COMMERCE CENTER |
221 W PHILADELPHIA ST. STE 60 |
YORK,
PA
17404
|
|
Correspondent Contact |
HELEN LEWIS |
Classification Product Code |
|
Date Received | 11/02/2010 |
Decision Date | 02/14/2011 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|