Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K221695 |
Device Name |
3M Filtek Supreme Flowable Restorative |
Applicant |
3M Company ESPE Dental Products |
2510 Conway Avenue |
St. Paul,
MN
55144
|
|
Applicant Contact |
Regina Feferman-Savvateev |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 872.3690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/10/2022 |
Decision Date | 06/13/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|