Wuxi Nickel New Material Co., Ltd
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- Biocompatible Nitinol Flat Wire with Shape Memory for Medical Use in Orthopedic
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Product Specification
Nitinol Round Wire Low-Force Superelastic Strand for Orthodontic Archwire & Root Canal Endodontic Files
1. Product Description
Manufactured with precision thermo-mechanical processing and medical-grade vacuum smelting, this dedicated nitinol round wire complies fully with ASTM F2063 industry standards for internal organ interventional applications. Tailored thermo-responsive transformation temperatures deliver reliable shape restoration under human physiological temperature, suited for repeated expansion and reset of urinary and gastrointestinal implant structures. The refined smooth surface resists mucus adhesion and bodily fluid erosion, effectively reducing postoperative blockage and inflammation risks. With stable superelasticity and low residual deformation, this wire maintains long-term structural stability inside humid internal organ environments, supporting durable minimally invasive treatment solutions for global urology and gastroenterology medical devices.
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2. Standard Parameter Table (Chemistry / Mechanical / Dimension / Executive Standard Calibrated)
| Classification |
Standard Spec |
Supplementary Medical Notes |
| Chemical Composition (wt%) |
Ni:54.5–57.0, Ti:Balance; C≤0.005, Fe≤0.025, O+N≤0.05, H≤0.002, Co/Cu/Cr≤0.005 |
VIM-VAR low-inclusion implant grade |
| Superelastic UTS (22°C Test) |
1000–1300 MPa |
Graded S/C/D alloy codes |
| Minimum Elongation |
≥10% |
Straightened SE delivery state |
| Upper Plateau Stress |
400–480 MPa |
Stable gentle vascular force output |
| Permanent Set after 6% Strain |
<0.5% |
Avoid device loosening inside vessels |
| Custom Af Temperature Range |
-30℃ ~ 70℃ |
10–30℃ grades optimized for human implantation |
| Diameter & Tolerance |
0.013–4.0mm; ±0.002~±0.02mm |
Micro filaments to thick basket strands |
| Surface Finishes for Medical Use |
Etched, bright polished, ultra-gloss ground |
Passive TiO₂ anti-corrosion film |
| Compliance Standards |
ASTM F2063-18, ASTM F2516-18, ISO 10993 |
Full biocompatibility validation |
| Supply Format |
Tangle-free spools, fixed cut lengths, compact coils |
Cleanroom secondary processing friendly |
3.Advantage
- Oral-temperature responsive shape memory generates steady mild alignment force, reducing frequent orthodontic adjustment visits
- Ultra-smooth polished wire minimizes bracket friction and oral mucosal abrasion to lower patient soreness during orthodontic treatment
- High cyclic fatigue resistance avoids premature wire deformation throughout multi-month tooth correction cycles
- Ultra-fine diameter variants support micro endodontic files for narrow, curved root canal cleaning and shaping
- Strictly controlled trace impurity levels pass oral biocompatibility testing to prevent gingival swelling or allergic reactions
- Multiple standardized spool lengths and straight cut pieces streamline mass production of orthodontic appliance components
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4. Application
nitinol round wire acts as core raw strand for cardiovascular guidewire cores, cerebral aneurysm capture snares, biliary stone retrieval baskets, ureteral stent braids and peripheral vascular intervention frames. It is widely selected by interventional medical device labs across North America, Europe and the Middle East for developing Class II/III disposable and permanent surgical implants used in cath labs and endoscopy centers worldwide.
5. FAQ
Q1: What Af temperature grade works best for routine orthodontic archwire production?
A: Grades with Af at 25±5℃ activate steady alignment force under natural oral temperature for comfortable tooth movement.
Q2: Can ultra-fine nitinol round wire be customized for narrow curved root canal files?
A: Micro diameters starting at 0.013mm are available with ultra-tight tolerances to match miniature endodontic instrument blueprints.
Q3: Will this nitinol wire trigger oral allergic reactions in patients?
A: Low-impurity VIM-VAR melt composition plus passivated surface limits nickel release and passes ISO 10993 oral biocompatibility assessments.
Q4: How long can superelastic orthodontic nitinol round wire maintain stable correction force?
A: The alloy retains consistent elastic performance over 6+ months without obvious force attenuation for full orthodontic alignment cycles.
Company Details
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Business Type:
Manufacturer
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Total Annual:
20000000-80000000
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Employee Number:
50~500
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Ecer Certification：
Verified Supplier
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