Device Classification Name |
Laser Activator For Polymerization
|
510(k) Number |
K201904 |
Device Name |
Monet Curing Laser |
Applicant |
CAO Group, Inc. |
4628 West Skyhawk Drive |
West Jordan,
UT
84084
|
|
Applicant Contact |
Robert K. Larsen |
Correspondent |
CAO Group, Inc. |
4628 West Skyhawk Drive |
West Jordan,
UT
84084
|
|
Correspondent Contact |
Robert K. Larsen |
Regulation Number | 872.6070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/09/2020 |
Decision Date | 11/24/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|