Brand Name | CERAM-X UNIVERSAL NANO-CERAMIC RESTORATIVE |
Type of Device | MATERIAL, TOOTH SHADE, RESIN |
Manufacturer (Section D) |
DENTSPLY DETREY GMBH |
detrey strasse 1 |
konstanz, 78467 |
GM 78467 |
|
Manufacturer (Section G) |
DENTSPLY DETREY GMBH |
detrey strasse 1 |
|
konstanz, 78467 |
GM
78467
|
|
Manufacturer Contact |
helen
lewis
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178457551
|
|
MDR Report Key | 6408950 |
MDR Text Key | 70071623 |
Report Number | 8010638-2017-00002 |
Device Sequence Number | 1 |
Product Code |
EBF
|
Combination Product (y/n) | N |
Reporter Country Code | NL |
PMA/PMN Number | K052097 |
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 |
Report Date |
02/24/2017 |
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 | 607.01.570 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/26/2017 |
Initial Date FDA Received | 03/16/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|