Brand Name | SMOOTHDRIVE |
Type of Device | HIGH-SPEED CONTRA ANGLE HANDPIECE |
Manufacturer (Section D) |
LARES RESEARCH |
295 lockheed avenue |
chico CA 95973 |
|
Manufacturer (Section G) |
LARES RESEARCH |
295 lockheed avenue |
|
chico CA 95973 |
|
Manufacturer Contact |
bruce
holderbein
|
295 lockheed avenue |
chico, CA 95973
|
5303451767
|
|
MDR Report Key | 19085324 |
MDR Text Key | 340682195 |
Report Number | 2916440-2024-00003 |
Device Sequence Number | 1 |
Product Code |
EGS
|
UDI-Device Identifier | D950135020 |
UDI-Public | D950135020 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K220874 |
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 |
04/09/2024 |
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 Model Number | 1:5 CA |
Device Catalogue Number | 13502 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/13/2024 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/13/2024 |
Initial Date FDA Received | 04/10/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/05/2023 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |