Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K070190 |
Device Name |
GRADIA DIRECT X |
Applicant |
GC AMERICA INC. |
3737 WEST 127TH STREET |
ALSIP,
IL
60803
|
|
Applicant Contact |
TERRY L JORITZ-LYONS |
Correspondent |
GC AMERICA INC. |
3737 WEST 127TH STREET |
ALSIP,
IL
60803
|
|
Correspondent Contact |
TERRY L JORITZ-LYONS |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 01/22/2007 |
Decision Date | 03/12/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|