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Clinical Evidence

4 mins·
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Zendura materials are engineered from the molecular level up — and measured, tested, and validated just as rigorously. This page collects the published material science, independent research, and real-world clinical experience behind Zendura aligner and retainer materials.

Material properties (standardized testing)
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Our flagship materials are characterized against internationally recognized ASTM standards. The table below summarizes values historically published for the rigid monolayer retainer material Zendura A and the patented tri-layer aligner material Zendura FLX:

PropertyASTM standardZendura A (monolayer)Zendura FLX (tri-layer)
Tensile modulusD638~2,400–2,650 MPa~1,000–1,200 MPa
Tensile strength (yield)D638~41–48 MPa~10–15 MPa
Tensile strength (break)D638~50 MPa~40–45 MPa
Flexural modulusD790~2,260 MPa (pre-forming)~1,100–1,200 MPa
Flexural strengthD790~90–110 MPa~35–45 MPa
Elongation at breakD638~100–130%>130–150%
Specific gravityD7921.20 g/cm³~1.19 g/cm³
Hardness (outer layer)D224082 Shore D~80 Shore D
Water absorption (24 h)D5700.18%~0.20%
Light transmissionD1003>90%>90%
HazeD1003<1.0%<1.0%

The contrast is intentional, not incidental: Zendura A’s toughness and rigidity make it the gold standard for long-term post-treatment retainers, while Zendura FLX’s patented structure — rigid outer shells over an elastomeric inner core — is tuned for active tooth movement.

Force delivery and stress relaxation
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Clear aligner therapy depends on a material’s ability to keep delivering light, continuous force inside a warm, wet environment (37 °C, ~100% relative humidity) for days at a time. Many materials lose most of their tooth-moving force within the first days of wear.

In stress-relaxation testing under in-mouth conditions (1–5% strain, 37 °C, 95–100% relative humidity, 24-hour cycles), historically published results show:

  • Zendura FLX requires ~40% lower initial insertion force for patient comfort, yet delivers up to 150% more continuous orthodontic force over a standard 7–10 day wear period than commodity PETG-based sheets, whose force decays rapidly.
  • Zendura A delivers high initial force and retains its shape against tooth-induced strain for up to three years of retainer wear without cracking.

Overcoming “creep” in hydrophilic polyurethane was itself an engineering breakthrough: conventional dry annealing fails because polyurethane loses its stress alignment on re-hydration, so Bay Materials developed and patented a process of annealing in a controlled, humid environment that preserves the hydrated structure while redistributing internal stress (US Patent No. 8,716,425).

Independent research
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Gingival-margin trim design has a larger effect on aligner retention than attachments. In a study published in the Journal of Clinical Orthodontics (Cowley, Mah & O’Toole, 2012), researchers measured the retention of thermoformed aligners with different margin designs:

  • Without attachments, a straight cut line 2 mm above the gingival zenith was about twice as retentive as a scalloped cut along the gingival margin.
  • With attachments, the same 2 mm trim was over four times as retentive as a scalloped cut.

In other words, how the appliance is trimmed can matter more to retention than adding composite attachments — a finding that directly informs our trimming guidance for Zendura appliances.

Clinical experience: in-office aligner fabrication
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Published field experience from True Dental Care (Jersey City, NJ), a general practice that moved the majority of its clear aligner production to an in-office digital workflow using Zendura FLX:

  • Patients reported little to no pain wearing FLX aligners.
  • The practice safely planned up to 0.5 mm of tooth movement per aligner.
  • The material delivered tooth-moving forces for well over 10 days of wear.
  • Sustained force retention and low discomfort allowed the wear cycle to be shortened from 14 days to 7 days per aligner.

Operationally, switching to in-office fabrication with Zendura FLX cut retainer turnaround from 2–3 weeks (outsourced) to 1–2 days — and grew aligner treatment to more than 20% of the practice’s business.


The data on this page reflects values and studies published to date; some figures originate from earlier product literature and are provided for reference. For the latest validation data, regulatory filings, or test certificates for a specific material, contact our team — and see each material’s Instructions for Use and Safety Data Sheet.