Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K183476 |
Device Name |
3M Filtek Universal Restorative |
Applicant |
3M ESPE Dental Products |
2510 Conway Ave. |
St. Paul,
MN
55144
|
|
Applicant Contact |
Lam Duong |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Mark Job |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 12/17/2018 |
Decision Date | 01/02/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|