Device Classification Name |
alloy, metal, base
|
510(k) Number |
K901552 |
Device Name |
(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE |
Applicant |
NOBELPHARMA USA, INC. |
5101 S. KEELER AVE. |
CHICAGO,
IL
60632
|
|
Applicant Contact |
RONALD DUDEK |
Correspondent |
NOBELPHARMA USA, INC. |
5101 S. KEELER AVE. |
CHICAGO,
IL
60632
|
|
Correspondent Contact |
RONALD DUDEK |
Regulation Number | 872.3710
|
Classification Product Code |
|
Date Received | 04/03/1990 |
Decision Date | 06/24/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|