FDA Device recall Z-0750-2025
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically su…
- FDA Device
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically su… by Straight Smile, citing virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindicati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0750-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-04 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Straight Smile |
| Distribution | US |
Product
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-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.
Reason
Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
Identifiers
| code_info | BYTE All-Day Aligner System Catalog Number: PRS-0063 UDI-DI code: 00850017524163 Lot Numbers: U.S. 17732803613 1541-876…BYTE All-Day Aligner System Catalog Number: PRS-0063 UDI-DI code: 00850017524163 Lot Numbers: U.S. 17732803613 1541-8760994451 1543-1100754821 1543-3414202891 1543-3432526751 1543-4235973091 1543-6917440011 1543-9520827111 1544-3697240661 1544-3701204981 1544-5456199651 1544-7224133161 1544-9091272701 1544-9711007881 1545-1892023561 1545-2829643331 1545-8723173781 1546-0149254981 1546-1844697261 1546-2431084621 1546-4535565811 1546-5302658721 1547-4352731881 1547-5049030711 1548-0962989131 1548-7930768331 1548-8608483691 1549-0109064461 1549-3476145071 1549-3914331141 1549-5604271371 1549-6288071031 1549-7431308041 1549-8157978931 1549-9114511321 1549-9463103781 1550-0849217361 1550-1755809801 1550-1808153641 1550-2472171981 1550-2742615371 1550-5987393421 1550-7942491181 1550-8978597191 1551-1922835701 1551-3703690751 1551-4047563861 1551-4819077851 1551-4826159631 1551-6464211451 1551-6492468971 1551-9010332821 1551-9847531111 1552-0753888851 1552-4909407241 1552-6104081791 1552-6878 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0750-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.