| Device Classification Name |
Cement, Dental
|
| 510(k) Number |
K842995 |
| Device Name |
EMA LIV CENERA DENTAL CEMENT |
| Applicant |
| Int'L Corp. |
| 7830 E. Redfield Rd. |
| Suite 12 |
|
Scottsdale ,
AZ
82560
|
|
| Applicant Contact |
DONALD MCKENZIE |
| Correspondent |
| Int'L Corp. |
| 7830 E. Redfield Rd. |
| Suite 12 |
|
Scottsdale ,
AZ
82560
|
|
| Correspondent Contact |
DONALD MCKENZIE |
| Regulation Number | 872.3275 |
| Classification Product Code |
|
| Date Received | 07/30/1984 |
| Decision Date | 10/30/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|