510(k) K230199 ยท NXC Aligner, Sequential
Byte Aligner System
| Applicant | Dentsply Sirona, Inc., York PA, US |
| Decision | Substantially Equivalent, Oct 18, 2023 |
| Received | Jan 25, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230199
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2024 | Straight Smile, LLC BYTE Aligner System REF PRS-0063
BYTE All-Day Aligner System
BYTE AT-Night Aligner System
A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self Open, Classified |
NXC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.