| Device Classification Name |
material, tooth shade, resin
|
|---|
| 510(K) Number |
K121880 |
|---|
| Models |
85072,
89107,
89463,
93885,
93886
|
| 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
|
|
| Contact |
lindsay tilton |
| Regulation Number | 872.3690
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 06/28/2012 |
|---|
| Decision Date | 09/25/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Dental
|
|---|
| Review Advisory Committee |
Dental
|
|---|
| statement |
statement
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
