Orthodontic Aligner Trays
Biocompatible LSR trays and dental components with optical clarity and zero flash.
Application Overview
Dental and orthodontic silicone parts — impression trays, aligner handling aids, cheek retractors — require a material that is soft, taste-free and optically clean. We mold platinum-cured LSR with medical pigments and optical-grade clarity, with surfaces smooth enough to avoid plaque traps. Custom durometer from 20 to 60 Shore A lets you tune retention force and patient comfort.
Technical Standards
- ✓ISO 10993-1 biocompatibility test reports for intra-oral contact
- ✓USP Class VI and FDA 21 CFR 177.2600 material grades
- ✓ISO 13485-aligned cleanroom production
- ✓Taste and odor screening on every material batch
Manufacturing Process
Trays are LSR injection molded in high-polish tools; optical clarity is preserved by avoiding release agents entirely.
- Mirror-polish tool cavities produce glossy, easy-to-clean surfaces
- Transparent and pastel medical-grade pigment dosing in closed system
- Flashless parting-line control eliminates hand deburring
- Cleanroom molding with double bagging ready for EO sterilization
Quality Inspection
- 🔍100% visual inspection (flash, short-shot, contamination) before packing
- 🔍Dimensional verification against approved drawing; FAI report on first shipment and after any tooling change
- 🔍Hardness per ASTM D2240 (Shore A) on every batch
- 🔍Lot traceability: material batch, cure records and operator logged for every carton
- 🔍Clarity and color verification against approved master sample
- 🔍Flash height measurement at parting line (≤0.05 mm typical)
- 🔍Tensile and elongation per ASTM D412 per batch
After-sales & Support
Every order ships with a Certificate of Conformance, First Article Inspection report and lot traceability records.
- Warranty: 12 months against material and workmanship defects
- Response: engineering reply within 24 hours, 8D report for confirmed quality issues
- Remedy: free replacement or credit for non-conforming batches; expedited re-shipment at our cost
- Support: free design-for-manufacturing review, material selection advice and sample policy for evaluation
- Recall readiness: full batch traceability enables targeted containment within 48 hours
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Need custom silicone parts?
From prototype samples to volume production — send us your drawing or sample for a quote within 24 hours.