Brand Name | BYTE DAY ALIGNER |
Type of Device | ALIGNER, SEQUENTIAL |
Manufacturer (Section D) |
STRAIGHT SMILE , LLC |
1556 20th st. , suite a |
santa monica CA 90404 |
|
Manufacturer (Section G) |
STRAIGHT SMILE , LLC |
1556 20th st. , suite a |
|
santa monica CA 90404 |
|
Manufacturer Contact |
dan
eagar
|
221 w. philadelphia st. |
york, PA 17401
|
7178494593
|
|
MDR Report Key | 19014377 |
MDR Text Key | 339049514 |
Report Number | 3014845255-2024-00213 |
Device Sequence Number | 1 |
Product Code |
NXC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K180346 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/01/2024 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/06/2024
|
Initial Date FDA Received | 04/01/2024 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|