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ISO13485 Injection Mold for Medical dental Devices PP Medical Level Material

As a leading manufacturer specializing in medical-grade dental plastic components, we deliver high-precision, biocompatible solutions tailored to the unique demands of the dental industry. Our products cover orthodontic appliances, restorative devices, disposable consumables, and dental tools—all engineered to meet strict global medical standards and enhance patient comfort, clinical efficiency, and treatment outcomes.
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  • YIXUN mold

  • 8480419090

Medical Dental Plastic Products: Precision Injection Molding Solutions

Introduction

As a leading manufacturer specializing in medical-grade dental plastic components, we deliver high-precision, biocompatible solutions tailored to the unique demands of the dental industry. Our products cover orthodontic appliances, restorative devices, disposable consumables, and dental tools—all engineered to meet strict global medical standards and enhance patient comfort, clinical efficiency, and treatment outcomes.

Core Product Series

1. Orthodontic Plastic Products

  • Key Offerings: Clear aligners, retainers, orthodontic traction devices, positioning brackets

  • Product Advantages:

✅ Ultra-transparent (light transmittance ≥92%) for discreet patient use
✅ Food-grade TPE/PMMA materials with excellent flexibility and durability
✅ Precision fit (±0.01mm tolerance) based on 3D oral scanning data
✅ Odor-free and non-irritating to oral mucosa
  • Application: Invisible orthodontic treatment, post-treatment retention, teeth alignment correction

2. Restorative Dental Components

  • Key Offerings: Temporary crowns/bridges, denture bases, implant abutment sleeves

  • Product Advantages:

✅ Biocompatible (ISO 10993 certified) with no cytotoxicity or sensitization
✅ High compressive strength (≥50MPa) to withstand chewing pressure
✅ Natural tooth color matching (Vita 3D shade system compliance)
✅ Polished surface for easy cleaning and plaque resistance
  • Application: Dental restoration, implant surgery, temporary tooth replacement

3. Disposable Dental Consumables

  • Key Offerings: Saliva ejectors, isolation brackets, dental syringe housings, impression trays

  • Product Advantages:

✅ Sterile packaging (ISO 11137 gamma irradiation, SAL ≥10⁻⁶)
✅ Cost-effective PP/PE materials with chemical stability
✅ Lightweight and ergonomic design for clinical convenience
✅ Environmentally friendly options (biodegradable materials available)
  • Application: Routine dental exams, cavity treatment, impression taking

4. Dental Auxiliary Tools

  • Key Offerings: Bite blocks, orthodontic positioners, protective face shields

  • Product Advantages:

✅ Dimensional stability (no deformation under oral temperature 32-42℃)
✅ Resistance to saliva and disinfectant corrosion
✅ Smooth edges to avoid oral mucosa irritation
✅ Customizable sizes for adults and children
  • Application: Dental procedure support, patient protection, treatment positioning

Material Excellence & Compliance

Premium Medical-Grade Materials

We exclusively use FDA/ISO approved materials to ensure safety and performance:
Material
Abbreviation
Key Features
Typical Applications
Polymethyl Methacrylate
PMMA
High transparency, easy polishing, biocompatible
Clear aligners, temporary crowns
Thermoplastic Elastomer
TPE/TPU
Flexibility, comfort, chemical resistance
Retainers, bite blocks
Polypropylene
PP
Sterilizable, low cost, high rigidity
Disposable consumables
Polyether Ether Ketone
PEEK
High strength, bone integration, durability
Implant abutments
Polycarbonate
PC
Impact resistance, heat resistance
Dental tool housings, face shields

Global Compliance Certifications

  • ISO 13485: Medical Device Quality Management System

  • ISO 10993: Biocompatibility Evaluation (Cytotoxicity, Sensitization, Irritation)

  • FDA 21CFR §177: Food Contact-Grade Plastic Materials

  • USP Class VI: Biological Reactivity Testing

  • CE Marking (MDR 2017/745): Compliance for EU Market

  • YY/T 0294: Chinese Dental Material Biocompatibility Standard

Our Manufacturing Advantages

1. Precision Molding Technology

  • CNC 5-axis machining for mold cavities (tolerance ±0.005mm)

  • Micro-channel cooling systems to prevent product deformation

  • Automated injection molding lines with real-time process monitoring

  • 3D scanning inspection for 100% dimensional verification

2. Sterile Production Environment

  • Class 7 Cleanroom (ISO 14644-1) for critical component manufacturing

  • Automated packaging with vacuum sealing to avoid contamination

  • Full production traceability (raw material batches, sterilization parameters, test results)

3. Customization Capabilities

  • Support for personalized designs based on patient oral scan data (STL/STEP files)

  • Rapid prototyping (3-7 days) for product validation

  • Flexible production runs (from 100-piece small batches to 1M+ high-volume orders)

  • Custom color matching, surface textures, and product modifications

4. Quality Control Process

  • Incoming inspection: Material certification verification (MTR)

  • In-process inspection: Real-time monitoring of injection pressure, temperature, and cycle time

  • Final inspection: CMM dimensional testing, biocompatibility sampling, and sterile testing

  • Post-delivery support: Defect analysis and mold optimization

Customization Process

  1. Requirement Sharing: Provide product 3D models, oral scan data, or application scenarios

  1. DFM Analysis: Optimize product design for manufacturability (wall thickness, draft angles)

  1. Mold Development: Rapid prototype mold (for sampling) or production mold (for mass production)

  1. Sample Testing: Validate biocompatibility, dimensional accuracy, and clinical fit

  1. Mass Production: Cleanroom manufacturing with strict quality control

  1. Delivery & Support: Provide batch traceability documents and technical after-sales service

Why Choose Us?

Medical-Grade Expertise: 10+ years of experience in dental plastic injection molding
Global Compliance: Full certification package for international market access
Precision & Consistency: Advanced equipment and strict QC to ensure product uniformity
Customer-Centric Service: One-stop solution from design to delivery
Sustainable Manufacturing: Environmentally friendly materials and energy-saving processes

Contact Us

Ready to bring your dental product ideas to life? Contact our engineering team for a free quote and technical consultation.


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