Brand Name | SIMPLANT GUIDE |
Type of Device | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS |
Manufacturer (Section D) |
DENTSPLY IMPLANTS N.V. |
research campus 10 |
hasselt limburg, B-350 0 |
BE B-3500 |
|
Manufacturer (Section G) |
DENTSPLY IMPLANTS N.V. |
research campus 10 |
|
hasselt limburg, B-350 0 |
BE
B-3500
|
|
Manufacturer Contact |
joleta
ness
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494593
|
|
MDR Report Key | 11795560 |
MDR Text Key | 249657573 |
Report Number | 9612468-2021-06815 |
Device Sequence Number | 1 |
Product Code |
NDP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
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 |
05/09/2021 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 37501 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/08/2021 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 05/09/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|