Device Classification Name |
diammine silver fluoride dental hypersensitivity varnish
|
510(k) Number |
K172047 |
Device Name |
Riva Star |
Applicant |
SDI Limited |
3-13 Brunsdon Street |
Bayswater,
AU
3153
|
|
Applicant Contact |
Ray Cahill |
Correspondent |
SDI Limited |
3-13 Brunsdon Street |
Bayswater,
AU
3153
|
|
Correspondent Contact |
Ray Cahill |
Regulation Number | 872.3260
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/06/2017 |
Decision Date | 04/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|