Brand Name | 3M ESPE FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE |
Type of Device | MATERIAL, TOOTH SHADE, RESIN |
Manufacturer (Section D) |
3M ESPE DENTAL PRODUCTS |
2510 conway avenue |
st. paul MN 55144 1000 |
|
Manufacturer (Section G) |
3M ESPE DENTAL PRODUCTS |
2510 conway avenue |
|
st. paul MN 55144 1000 |
|
Manufacturer Contact |
angie
draper
|
2510 conway avenue |
st. paul, MN 55144-1000
|
6517331179
|
|
MDR Report Key | 6205110 |
MDR Text Key | 63310545 |
Report Number | 3005174370-2016-00160 |
Device Sequence Number | 1 |
Product Code |
EBF
|
Combination Product (y/n) | N |
Reporter Country Code | AU |
PMA/PMN Number | K083610 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
12/05/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Dentist
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/05/2016 |
Initial Date FDA Received | 12/27/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|