Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K003361 |
Device Name |
RENEW LS-2 |
Applicant |
BISCO, INC. |
1100 WEST IRVING PARK RD. |
SCHAUMBURG,
IL
60193
|
|
Applicant Contact |
CYNDY ORIS |
Correspondent |
BISCO, INC. |
1100 WEST IRVING PARK RD. |
SCHAUMBURG,
IL
60193
|
|
Correspondent Contact |
CYNDY ORIS |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 10/27/2000 |
Decision Date | 11/28/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|