Brand Name | MIDWEST STYLUS LITE 360S |
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 |
karl
nittinger
|
221 w. philadelphia st. |
suite 60w |
york, pa
|
8494424
|
|
MDR Report Key | 9802280 |
MDR Text Key | 184716249 |
Report Number | 9614977-2020-00002 |
Device Sequence Number | 1 |
Product Code |
EFB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K003518 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
03/06/2020 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 791500 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/11/2020 |
Initial Date FDA Received | 03/06/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|