InjuryNXC
Byte Night Aligners
Received Jul 31, 2026
Report 3031789024-2026-02836 · MDR key 50107471
Device
Generic name
Aligner, Sequential
Manufacturer
Straight Smile LlcModel number
NBYTETrayCatalog number
PRS-0063
Lot number
SN3771CMCT
Product problems
- Patient-Device Incompatibility
Patient
Unknown
- Deformity/ Disfigurement
- Tissue Breakdown
Narrative
Description of Event or Problem
Patient stated that they experienced bite concerns, TMJ, and overbite due to Byte aligners.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 CFR Part 803.