Device Classification Name |
Laser, Fluorescence Caries Detection
|
510(k) Number |
K121685 |
Device Name |
SOPROCARE |
Applicant |
SOPRO |
124 GAITHER DRIVE |
SUITE 140 |
MT. LAUREL,
NJ
08054
|
|
Applicant Contact |
RICK ROSATI |
Correspondent |
SOPRO |
124 GAITHER DRIVE |
SUITE 140 |
MT. LAUREL,
NJ
08054
|
|
Correspondent Contact |
RICK ROSATI |
Regulation Number | 872.1745
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/07/2012 |
Decision Date | 03/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|