Read the figures for yourself.
Selected figures from Graphy's material and clinical characterisation, redrawn from the published studies behind Graphy's summary. The headline results are rebuilt as our own charts on the Technology page; this page is the source material behind them.
Every figure on this page is redrawn from the published study or test report it cites, using the figures the authors report. Two things are deliberately not here: figures characterising Graphy's prosthetics resins, which describe a different material class to the aligner, and case-report imagery showing identifiable patients. Journal article pages are not reproduced either. Each paper is linked to its publisher record on the Technology page.
| Test | Standard | Result | Report |
|---|---|---|---|
| Cytotoxicity (elution method) | ISO 10993-5 | Non-cytotoxic to L-929 mouse fibroblast cells | BIO-GNT 1384 |
| Sensitization (GPMT) | ISO 10993-10 | Non-sensitizer to guinea pig skin | BIO-ATX 3190 |
| Irritation (acute oral mucosa) | ISO 10993-10 | Oral mucosal irritation index of zero | BIO-ATX 3191 |
| Intracutaneous reactivity | ISO 10993-10 | Non-irritant to rabbit skin | BIO-ATX 3192 |
| Acute systemic toxicity | ISO 10993-11 | No systemic toxicity in mice at 50 mL/kg | BIO-ATX 3193 |
| Subacute systemic toxicity | ISO 10993-11 | No gross or microscopic changes in rats | BIO-CTX 606 |
| Subchronic systemic toxicity | ISO 10993-11 | No gross or microscopic changes in rats | BIO-CTX 362 |
| Genotoxicity (bacterial reverse mutation) | ISO 10993-3 | Non-mutagenic at 100% extract | BIO-GNT 1385 |
| Genotoxicity (chromosomal aberration) | ISO 10993-3 | Non-clastogenic with and without metabolic activation | BIO-GNT 1386 |
| Elapsed time | |||||||
|---|---|---|---|---|---|---|---|
| Elapsed time | 0 | 10 sec | 30 sec | 1 min | 5 min | 10 min | 60 min |
| Bending angle (°) | 177.00 ± 1.44 | 146.27 ± 3.92 | 107.23 ± 7.05 | 79.43 ± 6.45 | 31.53 ± 5.48 | 20.32 ± 5.49 | 6.90 ± 2.68 |
| Shape recovery ratio (%) | 0 | 17.36 ± 2.06 | 39.42 ± 3.90 | 55.12 ± 3.64 | 82.19 ± 3.09 | 88.52 ± 3.10 | 96.11 ± 1.50 |
- Stiffness falls as it warms. Storage modulus drops markedly from 30 to 40 °C, then levels off above 40 °C.
- Thickness matters when cool. At 30 °C the thicker specimens (0.5, 0.65 and 0.8 mm tested) reached a much higher peak force.
- Less so at mouth temperature. Above 40 °C the link between thickness and peak force was no longer significant.
| After 14 days at 37 °C | Force at 1% strain | Force at 3% strain |
|---|---|---|
| Direct-printed resins (TC-85, TA-28, TR-07) | 4.04 to 7.24 N | 7.30 to 13.48 N |
| Thermoformed (Zendura A, Zendura FLX) | 26.26 to 32.91 N | 32.91 to 65.23 N |
- Formed byThermoforming over a printed master
- ProfileHalf-round, hollow
- Test specimen7 × 8 mm, hollow RPA
- LoadCompression between two platens
- Formed byDirect 3D printing
- ProfileRectangular block, hollow or filled
- Test specimen7 × 8 mm, hollow or filled CPR
- LoadCompression between two platens