Brand Name | SOLO DIAMOND |
Type of Device | DIAMOND, DENTAL BURR |
Manufacturer (Section D) |
PREMIER DENTAL PRODUCTS COMPANY |
1710 romano drive |
plymouth meeting PA 19462 |
|
Manufacturer (Section G) |
ABRASIVE TECHNOLOGY, LLC |
8400 green meadows drive n. |
|
lewis center OH 43035 |
|
Manufacturer Contact |
jessica
huang
|
1710 romano drive |
plymouth meeting 19462
|
6102396069
|
|
MDR Report Key | 17646339 |
MDR Text Key | 322296295 |
Report Number | 2511556-2023-00005 |
Device Sequence Number | 1 |
Product Code |
DZP
|
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,Company Representative |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
08/02/2023 |
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 | 811037C |
Device Lot Number | M0116477 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/02/2023 |
Initial Date FDA Received | 08/29/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/10/2023 |
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) |
Other;
|
|
|