| Device Classification Name |
liner, cavity, calcium hydroxide
|
|---|
| 510(K) Number |
K122421 |
|---|
| Models |
1210-KA,
1216-KA,
1217-KA
|
| Device Name |
TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID |
|---|
| Applicant |
| KURARAY NORITAKE DENTAL INC. |
| ote center bldg 7f |
| 1-1-3, otemachi |
|
chiyoda-ku,
|
|
| Contact |
michio takigawa |
| Regulation Number | 872.3250
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/09/2012 |
|---|
| Decision Date | 12/11/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Dental
|
|---|
| Review Advisory Committee |
Dental
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
