Device Classification Name |
diammine silver fluoride dental hypersensitivity varnish
|
510(k) Number |
K102973 |
FOIA Releasable 510(k) |
K102973
|
Device Name |
SILVER DENTAL ARREST |
Applicant |
COOLEY CONSULTING, INC. |
531 CHISHOLM TRAIL |
wyoming,
OH
45215
|
|
Applicant Contact |
william cooley |
Correspondent |
COOLEY CONSULTING, INC. |
531 CHISHOLM TRAIL |
wyoming,
OH
45215
|
|
Correspondent Contact |
william cooley |
Regulation Number | 872.3260
|
Classification Product Code |
|
Date Received | 10/06/2010 |
Decision Date | 07/31/2014 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
statement |
statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|