Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K182778 |
Device Name |
LC GLOSSFILL XR |
Applicant |
S&C Polymer Silicon- und Composite Spezialitaeten GmbH |
Robert-Bosch-Str. 2 |
Elmshorn,
DE
25335
|
|
Applicant Contact |
Christian Boettcher |
Correspondent |
S&C Polymer Silicon- und Composite Spezialitaeten GmbH |
Robert-Bosch-Str. 2 |
Elmshorn,
DE
25335
|
|
Correspondent Contact |
Christian Boettcher |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 10/01/2018 |
Decision Date | 04/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|