Device Classification Name |
Laser, Fluorescence Caries Detection
|
510(k) Number |
K043156 |
Device Name |
D-CARIE, MODEL N121-M1 |
Applicant |
NEKS TECHNOLOGIES, INC. |
208 BARRINGTON OVERLOOK DRIVE |
DURHAM,
NC
27703
|
|
Applicant Contact |
CHARLES H KYPER |
Correspondent |
NEKS TECHNOLOGIES, INC. |
208 BARRINGTON OVERLOOK DRIVE |
DURHAM,
NC
27703
|
|
Correspondent Contact |
CHARLES H KYPER |
Regulation Number | 872.1745
|
Classification Product Code |
|
Date Received | 11/15/2004 |
Decision Date | 04/28/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|