Brand Name | MIDWEST TRADITION HANDPIECE |
Type of Device | HANDPIECE, AIR-POWERED, DENTAL |
Manufacturer (Section D) |
SIRONA DENTAL SYSTEMS GMBH |
fabrikstrasse 31 |
bensheim, hessen D-646 25 |
GM D-64625 |
|
Manufacturer (Section G) |
SIRONA DENTAL SYSTEMS GMBH |
fabrikstrasse 31 |
|
bensheim, hessen D-646 25 |
GM
D-64625
|
|
Manufacturer Contact |
hannah
seevaratnam
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494593
|
|
MDR Report Key | 12725502 |
MDR Text Key | 279292301 |
Report Number | 9614977-2021-00062 |
Device Sequence Number | 1 |
Product Code |
EFB
|
Combination Product (y/n) | N |
PMA/PMN Number | K131319 |
Number of Events Reported | 1 |
Summary Report (Y/N) | Y |
Report Source |
Manufacturer
|
Type of Report
| Initial |
Report Date |
10/30/2021 |
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 |
No Information
|
Device Catalogue Number | 790044 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/30/2021 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|