Device Classification Name |
resin, denture, relining, repairing, rebasing
|
510(k) Number |
K141439 |
Device Name |
ORTHODONTIC ACRYLIC (NOT FINALIZED) |
Applicant |
BISCO, INC. |
1100 WEST IRVING PARK RD. |
SCHAUMBURG,
IL
60193
|
|
Applicant Contact |
Michelle Schiltz-Taing |
Correspondent |
BISCO, INC. |
1100 WEST IRVING PARK RD. |
SCHAUMBURG,
IL
60193
|
|
Correspondent Contact |
Michelle Schiltz-Taing |
Regulation Number | 872.3760
|
Classification Product Code |
|
Date Received | 06/02/2014 |
Decision Date | 09/12/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|