Z-0750-2025.jsonld
type: Dataset
name: 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.
description: FDA recall Z-0750-2025 — Straight Smile, LLC is recalling 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. (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: MedicalDevice
  name: 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.
  manufacturer: Straight Smile, LLC
claims: enforcement-record
claims: FDA classified recall Z-0750-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0750-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0750-2025
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Straight Smile, LLC
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: 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.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-11-04
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 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 1552-6878824261 1552-8348951001 1552-9637841291 1553-2183553251 1553-2206830171 1553-2207770561 1553-2992105981 1553-3788082031 1553-4691850681 1553-4819545741 1553-6209164371 1553-6356195311 1553-8127560541 1554-1370747371 1554-1428423581 1554-2656842861 1554-5042086951 1554-7281718421 1554-8288641491 1554-8707038231 1555-3544992291 1555-3614935151 1555-3806544901 1555-3834122151 1555-3919827611 1555-6333750931 1555-7778547971 1555-8144440311 1555-9646933391 1556-0762886881 1556-1355725571 1556-2230465841 1556-2330493811 1556-7458327891 1556-8306741391 1556-8975364901 1556-9136131491 1556-9683523151 1556-9785712361 1557-0633333971 1557-0786471341 1557-2521467831 1557-5035066281 1557-5376071891 1557-5533727181 1557-6908739091 1557-6947760051 1557-7793290501 1557-7798446801 1557-7849841961 1557-8153394341 1558-3110394071 1558-3129845601 1558-6256910061 1558-6278187251 1558-7110412931 1558-7199597371 1558-8205199651 1558-8219047301 1558-8399027481 1559-0179512811 1559-0701112081 1559-2254122271 1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - U.S. Nationwide distribution including in the states of CO, KS, MI, IL, GA NY, MN, IN, PA, TX, NJ, MS, RI, SD, FL, KY, CA, OR, WI, WY, MA, NC, WA, AR, UT, OH, SC, NM, CT, TN, LA, NE, AL, MO, VA, MD, IA, OK, NV, DE, VT, AZ, RI, HI, WV, NH, MT, AK, ID, Puerto Rico, ME and the countries of Australia.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0750-2025: Straight Smile, LLC is recalling 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.
text: The FDA logged enforcement record Z-0750-2025: Straight Smile, LLC is voluntarily recalling 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-04. Affected lots/codes: 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 1552-6878824261 1552-8348951001 1552-9637841291 1553-2183553251 1553-2206830171 1553-2207770561 1553-2992105981 1553-3788082031 1553-4691850681 1553-4819545741 1553-6209164371 1553-6356195311 1553-8127560541 1554-1370747371 1554-1428423581 1554-2656842861 1554-5042086951 1554-7281718421 1554-8…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-0750-2025 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.