Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K121915 |
Device Name |
BRIGHT RESTORATIVE MATERIALS |
Applicant |
DMP LTD |
KALYVION AVENUE |
MARKOPOULO INDUSTRIAL ZONE |
MARKOPOULO, ATTIKI,
GR
19003
|
|
Applicant Contact |
DIMITRIS PRANTSIDIS |
Correspondent |
DMP LTD |
KALYVION AVENUE |
MARKOPOULO INDUSTRIAL ZONE |
MARKOPOULO, ATTIKI,
GR
19003
|
|
Correspondent Contact |
DIMITRIS PRANTSIDIS |
Regulation Number | 872.3690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/02/2012 |
Decision Date | 09/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|