Device Classification Name |
Cleanser, Root Canal
|
510(k) Number |
K053167 |
Device Name |
BIOPURE MTAD ROOT CANAL CLEANSER |
Applicant |
DENTSPLY INTL., INC. |
SUSQUEHANNA COMMERCE CENTER |
221W PHILADELPHIA ST. SUITE 60 |
YORK,
PA
17404
|
|
Applicant Contact |
HELEN LEWIS |
Correspondent |
DENTSPLY INTL., INC. |
SUSQUEHANNA COMMERCE CENTER |
221W PHILADELPHIA ST. SUITE 60 |
YORK,
PA
17404
|
|
Correspondent Contact |
HELEN LEWIS |
Classification Product Code |
|
Date Received | 11/14/2005 |
Decision Date | 12/08/2005 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|