Brand Name | ROOT FILLER L |
Type of Device | INSTRUMENT, FILLING, PLASTIC, DENTAL |
Manufacturer (Section D) |
DENTSPLY VDW GMBH |
bayerwaldstrasse 15 |
munich, 81737 |
GM 81737 |
|
Manufacturer (Section G) |
DENTSPLY VDW GMBH |
bayerwaldstrasse 15 |
|
munich, 81737 |
GM
81737
|
|
Manufacturer Contact |
helen
lewis
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494229
|
|
MDR Report Key | 7366872 |
MDR Text Key | 103555228 |
Report Number | 9611053-2018-00029 |
Device Sequence Number | 1 |
Product Code |
EIY
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | NA |
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,Followup |
Report Date |
05/22/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | V040393021035 |
Device Lot Number | 179031 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/23/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/23/2018 |
Initial Date FDA Received | 03/23/2018 |
Supplement Dates Manufacturer Received | 05/07/2018
|
Supplement Dates FDA Received | 05/22/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|