| Device Classification Name |
Alloy, Metal, Base
|
| 510(k) Number |
K021968 |
| Device Name |
CERALOY SOLDER |
| Applicant |
| Neirynck & Vogt NV |
| 12960 Stonecreek Dr. |
|
Pickerington,
OH
43147
|
|
| Applicant Contact |
JOSH ANDRACHEK |
| Correspondent |
| Neirynck & Vogt NV |
| 12960 Stonecreek Dr. |
|
Pickerington,
OH
43147
|
|
| Correspondent Contact |
JOSH ANDRACHEK |
| Regulation Number | 872.3710 |
| Classification Product Code |
|
| Date Received | 06/17/2002 |
| Decision Date | 07/26/2002 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|