Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K121880 |
Device Name |
DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID |
Applicant |
DANVILLE MATERIALS, INC. |
3420 Fostoria Way Ste A200 |
SAN RAMON,
CA
94583
|
|
Applicant Contact |
LINDSAY TILTON |
Correspondent |
DANVILLE MATERIALS, INC. |
3420 Fostoria Way Ste A200 |
SAN RAMON,
CA
94583
|
|
Correspondent Contact |
LINDSAY TILTON |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 06/28/2012 |
Decision Date | 09/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|