Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K190758 |
Device Name |
Opus Bulk Fill APS, Opus Bulk Fill Flow APS |
Applicant |
DentsCare LTDA |
Av. Edgar Nelson Meister, 474 |
Joinville,
BR
89219-501
|
|
Applicant Contact |
Roberta Uyara |
Correspondent |
United Regulatory LLC |
12343 NW 25th St |
Coral Springs,
FL
33065
|
|
Correspondent Contact |
Rodrigo Abreu |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 03/25/2019 |
Decision Date | 09/04/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|