Device Classification Name |
material, impression
|
510(k) Number |
K050013 |
Device Name |
RETRACTOFOAM |
Applicant |
COLTENE/WHALEDENT AG |
1349 LEXINGTON AVENUE |
NEW YORK,
NY
10128
|
|
Applicant Contact |
HENRY J VOGELSTEIN |
Correspondent |
COLTENE/WHALEDENT AG |
1349 LEXINGTON AVENUE |
NEW YORK,
NY
10128
|
|
Correspondent Contact |
HENRY J VOGELSTEIN |
Regulation Number | 872.3660
|
Classification Product Code |
|
Date Received | 01/03/2005 |
Decision Date | 02/09/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|