Brand Name | MIDWEST TRADITION PLUS FIXED BACK END |
Type of Device | HANDPIECE, AIR-POWERED, DENTAL |
Manufacturer (Section D) |
SIRONA DENTAL SYSTEMS GMBH |
fabrikstrasse 31 |
bensheim, D-646 25 |
GM D-64625 |
|
Manufacturer (Section G) |
SIRONA DENTAL SYSTEMS GMBH |
fabrikstrasse 31 |
|
bensheim, D-646 25 |
GM
D-64625
|
|
Manufacturer Contact |
karl
nittinger
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494424
|
|
MDR Report Key | 9262990 |
MDR Text Key | 184717109 |
Report Number | 9614977-2019-00132 |
Device Sequence Number | 1 |
Product Code |
EFB
|
Combination Product (y/n) | N |
PMA/PMN Number | K963050 |
Number of Events Reported | 1 |
Summary Report (Y/N) | Y |
Report Source |
Manufacturer
|
Type of Report
| Initial |
Report Date |
10/31/2019 |
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 | 770044 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/31/2019 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|