Brand Name | X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE |
Type of Device | HANDPIECE, DIRECT DRIVE, AC-POWERED |
Manufacturer (Section D) |
DENTSPLY MAILLEFER |
chemin du verger 3 |
ballaigues, 1338 |
SZ 1338 |
|
MDR Report Key | 12285458 |
MDR Text Key | 267476999 |
Report Number | 8031010-2021-00181 |
Device Sequence Number | 1 |
Product Code |
EKX
|
Combination Product (y/n) | N |
PMA/PMN Number | K990682 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other |
Type of Report
| Initial,Followup |
Report Date |
10/12/2021 |
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 |
Health Professional
|
Device Catalogue Number | A100400000000 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 08/05/2021 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 10/12/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|