Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K121769 |
Device Name |
DENTOCORE / DENTOCORE BODY |
Applicant |
ITENA CLINICAL |
500 BOUL CARTIER WEST |
LAVAL,
CA
H7V 5B7
|
|
Applicant Contact |
LOUIS- PAUL MARIN |
Correspondent |
ITENA CLINICAL |
500 BOUL CARTIER WEST |
LAVAL,
CA
H7V 5B7
|
|
Correspondent Contact |
LOUIS- PAUL MARIN |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 06/15/2012 |
Decision Date | 03/05/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|