Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K062343 |
Device Name |
GRANDIO FLOW TRY-IN |
Applicant |
VOCO GMBH |
ANTON-FLETTNER-STRASSE 1-3 |
CUXHAVEN,
DE
D-27472
|
|
Applicant Contact |
MICHAEL SUES |
Correspondent |
VOCO GMBH |
ANTON-FLETTNER-STRASSE 1-3 |
CUXHAVEN,
DE
D-27472
|
|
Correspondent Contact |
MICHAEL SUES |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 08/11/2006 |
Decision Date | 11/02/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|