Device Classification Name |
Diagnostic Light, Soft Tissue Detector
|
510(k) Number |
K073483 |
Device Name |
SAPPHIRE O/E ORAL EXAMINATION SYSTEM |
Applicant |
DEN-MAT HOLDINGS, LLC |
2727 SKYWAY DR. |
SANTA MARIA,
CA
93455
|
|
Applicant Contact |
ALAN MATTHEWS |
Correspondent |
DEN-MAT HOLDINGS, LLC |
2727 SKYWAY DR. |
SANTA MARIA,
CA
93455
|
|
Correspondent Contact |
ALAN MATTHEWS |
Regulation Number | 872.6350
|
Classification Product Code |
|
Date Received | 12/11/2007 |
Decision Date | 04/03/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|