Device Classification Name |
Activator, Ultraviolet, For Polymerization
|
510(k) Number |
K042196 |
Device Name |
SAVEDENT BLUE |
Applicant |
DENFOTEX LIGHT SYSTEMS LTD |
UNIT 15, BELLEKNOWES IND.EST |
INVERKEITHING FIFE, SCOTLAND,
GB
KY11 1H7
|
|
Applicant Contact |
JOHN COLLES |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
WILLIAM J SAMMONS |
Regulation Number | 872.6070
|
Classification Product Code |
|
Date Received | 08/13/2004 |
Decision Date | 11/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|