Device Classification Name |
cement, dental
|
510(k) Number |
K112574 |
Device Name |
PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT |
Applicant |
PRIME DENTAL MANUFACTURING, INC. |
4555 WEST ADDISON STREET |
CHICAGO,
IL
60641
|
|
Applicant Contact |
JAVIER ALVAREZ |
Correspondent |
PRIME DENTAL MANUFACTURING, INC. |
4555 WEST ADDISON STREET |
CHICAGO,
IL
60641
|
|
Correspondent Contact |
JAVIER ALVAREZ |
Regulation Number | 872.3275
|
Classification Product Code |
|
Date Received | 09/06/2011 |
Decision Date | 01/23/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|