FDA Adverse Event
Injury
Summary report: N
BYTE DAY ALIGNERS
MDR report key: 21409181
·
Received February 19, 2025
Report
- Report Number
- 3031789024-2025-00418
- Event Type
- Injury
- Date Received
- February 19, 2025
- Report Date
- October 23, 2025
- Manufacturer
- STRAIGHT SMILE, LLC
- Product Code
- NXC
- UDI-DI
- 00850017524163
- PMA / PMN Number
- K230199
- Removal / Correction Number
- Z-0750-2025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803.
Additional Manufacturer Narrative · 0
A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.
Description of Event or Problem · 0
THE PATIENT REPORTED DENTIST RECOMMENDED TO STOP TREATMENT DUE TO TMJ ISSUES AND OVERJET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44454 | BYTE DAY ALIGNERS | ALIGNER, SEQUENTIAL | NXC | STRAIGHT SMILE, LLC | HBYTE TRAY | 00850017524163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |