Device Classification Name |
Cord, Retraction
|
510(k) Number |
K152064 |
Device Name |
Astringedent Clear |
Applicant |
ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH |
SOUTH JORDAN,
UT
84095
|
|
Applicant Contact |
COREY JASEPH |
Correspondent |
ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH |
SOUTH JORDAN,
UT
84095
|
|
Correspondent Contact |
COREY JASEPH |
Classification Product Code |
|
Date Received | 07/24/2015 |
Decision Date | 09/24/2015 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|