Brand Name | MIDWEST E PRO 1:1 HIGH SPEED CONTRA ANGLE ATTACHMENT |
Type of Device | HANDPIECE, AIR-POWERED, DENTAL |
Manufacturer (Section D) |
SIRONA DENTAL SYSTEMS GMBH |
fabrikstrasse 31 |
bensheim, hessen D-646 25 |
GM D-64625 |
|
MDR Report Key | 11758369 |
MDR Text Key | 251767257 |
Report Number | 9614977-2021-00024 |
Device Sequence Number | 1 |
Product Code |
EFB
|
Combination Product (y/n) | N |
PMA/PMN Number | K972436 |
Number of Events Reported | 1 |
Summary Report (Y/N) | Y |
Report Source |
Manufacturer
|
Type of Report
| Initial,Followup |
Report Date |
06/09/2021 |
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? |
No
|
Device Operator |
No Information
|
Device Catalogue Number | 875110 |
Device Lot Number | 20616 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 04/30/2021 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/09/2021
|
Patient Sequence Number | 1 |
|
|