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Status update (August 21, 2025): Dentsply Sirona paused shipment and processing of new and recently placed Byte Aligner and impression-kit orders in late October 2024 while reviewing regulatory requirements with the FDA. On January 14, 2025, the company announced it is not reinstating the at-home Byte Aligner Systems or impression kits and plans to refocus Byte around treatments with expanded in-person dentist oversight. Existing, non-contraindicated patients should contact their treating dentist via the Patient Account Center or the My Byte app.
1) Screening and contraindications
Byte said its onboarding workflow “may not provide adequate assurance” that certain contraindicated patients (for example, active periodontal disease, severe open bite or overjet, surgical cases, mixed dentition, dental prosthetics or implants, adolescents with skeletally narrow jaws) would be kept out of treatment. The company advised those groups to stop and see a dentist.
2) Changing state-level rules
Separate from safety, Dentsply Sirona cited state regulatory trends—especially requirements for in-person exams and, in some states, recent radiographs before moving teeth—as adverse to direct-to-consumer orthodontics. Examples include recent measures in Florida and Texas and earlier patient-protection rules in California. Requirements and enforcement vary by state.
3) FDA recall listing
The FDA posted a Class II recall for the Byte Aligner System in December 2024; the listing remains on the agency’s database.
If you haven’t started treatment:
If you’re currently in treatment:
Retainers and supplies:
Before the pause, Byte marketed two plans—All-Day and At-Night—plus a mouthpiece (“HyperByte”) that delivered high-frequency vibration (HFV) during treatment. These details are historical and should not be treated as current availability.
About HFV devices generally: the VPro device (used by dental professionals and formerly under Propel Orthodontics, now within Dentsply Sirona) has an FDA 510(k) clearance as an “orthodontic vibratory accessory” (K183018). Evidence for faster tooth movement with HFV varies by study; individual outcomes differ. This note does not imply efficacy for Byte’s at-home model, which is not being reinstated.
Given Byte’s paused/not-reinstated status, we’re freezing our historical ratings and removing a current overall score. You’ll still see our pre-pause impressions below for transparency.
Status: Unavailable / Not Rated (frozen as of October 2024).
Historical testing notes (pre-Oct 2024)
(These notes reflect pre-pause experiences and should not be interpreted as current availability or endorsement.)
| Brand | Who it’s for | How you start | Monitoring | Availability |
|---|---|---|---|---|
| Byte | — | Not available | — | Paused / not reinstated |
| Invisalign | Mild to complex | In-person exam with a dentist/orthodontist | In-person | Widely available through local providers |
| CandidPro (hybrid) | Mild to some complex (provider dependent) | In-person exam with a CandidPro dentist | Remote + in-office | Provider-based |
| Motto (Aspen) | Mild to complex | In-person exam at Aspen Dental | In-person or hybrid | Clinic-based |
| Other mail-order brands | Varies | Check current state rules and provider oversight | Remote | Verify regulatory status in your state |
Important: Laws in several states now require an in-person exam before any orthodontic tooth movement. If you’re comparing options, ask the provider how they meet your state’s requirements and what radiographs or records they use before treatment.
We re-checked primary sources (company notices, FDA databases, and professional-association updates) and revised this page to reflect current status as of August 21, 2025. We removed or relabeled historical claims (timelines, pricing, guarantees), froze prior ratings, and added concrete next steps for existing patients.
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