| Device Classification Name |
Cleanser, Root Canal
|
| 510(k) Number |
K992484 |
| Device Name |
RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG |
| Applicant |
| Jordco, Inc. |
| 595 NW 167th Ave. |
|
Beaverton,
OR
97006
|
|
| Applicant Contact |
HAL J OIEN |
| Correspondent |
| Jordco, Inc. |
| 595 NW 167th Ave. |
|
Beaverton,
OR
97006
|
|
| Correspondent Contact |
HAL J OIEN |
| Classification Product Code |
|
| Date Received | 07/26/1999 |
| Decision Date | 10/14/1999 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Dental
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|