Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K191385 |
Device Name |
BRILLIANT COMPONEER |
Applicant |
Coltene/Whaledent AG |
Feldwiesenstrasse 20 |
altstatten,
CH
9450
|
|
Applicant Contact |
wolfgang dorner |
Correspondent |
Coltene/Whaledent AG |
Feldwiesenstrasse 20 |
altstatten,
CH
9450
|
|
Correspondent Contact |
wolfgang dorner |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 05/23/2019 |
Decision Date | 10/29/2019 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|