Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K083610 |
Device Name |
FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE |
Applicant |
3M COMPANY |
3M CENTER,BLDG. 275-2W-08 |
ST. PAUL,
MN
55144 -1000
|
|
Applicant Contact |
SCOTT ERICKSON |
Correspondent |
3M COMPANY |
3M CENTER,BLDG. 275-2W-08 |
ST. PAUL,
MN
55144 -1000
|
|
Correspondent Contact |
SCOTT ERICKSON |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 12/08/2008 |
Decision Date | 12/17/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|