Brand Name | 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 1000 (LOW-HIGH POWER) |
Type of Device | SCALER, ULTRASONIC |
Manufacturer (Section D) |
DENTSPLY PROFESSIONAL |
1301 smile way |
york PA 17404 |
|
Manufacturer (Section G) |
DENTSPLY PROFESSIONAL |
1301 smile way |
|
york PA 17404 |
|
Manufacturer Contact |
helen
lewis
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494229
|
|
MDR Report Key | 5307588 |
MDR Text Key | 34576245 |
Report Number | 2424472-2015-00121 |
Device Sequence Number | 1 |
Product Code |
ELC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K052334 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial,Followup |
Report Date |
11/17/2015 |
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 | 81570 |
Device Lot Number | 5063 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/24/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/17/2015
|
Initial Date FDA Received | 12/17/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/27/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/04/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|