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 |
helen
lewis
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494229
|
|
MDR Report Key | 6785565 |
MDR Text Key | 82402639 |
Report Number | 3007362683-2017-00001 |
Device Sequence Number | 1 |
Product Code |
NDP
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial,Followup |
Report Date |
03/29/2018 |
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 | 37501 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/11/2017 |
Initial Date FDA Received | 08/10/2017 |
Supplement Dates Manufacturer Received | 03/06/2018
|
Supplement Dates FDA Received | 03/29/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/18/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|