Device Classification Name |
Powder, Porcelain
|
510(k) Number |
K992161 |
Device Name |
CERANA |
Applicant |
NORDISKA DENTAL AB |
1205 DE LA VINA |
SANTA BARBARA,
CA
93101
|
|
Applicant Contact |
CHRISTINE EMANUEL |
Correspondent |
NORDISKA DENTAL AB |
1205 DE LA VINA |
SANTA BARBARA,
CA
93101
|
|
Correspondent Contact |
CHRISTINE EMANUEL |
Regulation Number | 872.6660
|
Classification Product Code |
|
Date Received | 06/25/1999 |
Decision Date | 09/22/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|