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 |
|
Manufacturer (Section G) |
NAKANISHI INC. |
700 shimohinata |
|
kanuma-shi, 322-8 666 |
JA
322-8666
|
|
Manufacturer Contact |
karl
nittinger
|
221 w. philadelphia st. |
suite 60w |
york, pa
|
8494424
|
|
MDR Report Key | 10431875 |
MDR Text Key | 203718036 |
Report Number | 8031010-2020-00064 |
Device Sequence Number | 1 |
Product Code |
EKX
|
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | K990682 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
08/20/2020 |
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? |
No
|
Initial Date Manufacturer Received |
03/16/2020
|
Initial Date FDA Received | 08/20/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/02/2018 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |