Quality Control Standards & Procedures
Exceldent Dental Technology Development Co., Ltd.
1. Quality Policy & Compliance
We strictly follow ISO 13485, medical device GMP, and YY standards for customized dentures. We implement full-process traceable quality control to ensure every product is safe, precise, comfortable and durable.
2. Core Quality Control Standards
Raw Material Standards
- All materials (zirconia, Co-Cr alloy, titanium alloy, denture base polymers, etc.) hold valid registration certificates, inspection reports and biocompatibility certifications.
- Each batch is inspected for purity, strength, corrosion resistance, non-toxicity and non-sensitization.
- Full batch records and samples are retained for no less than 5 years for full traceability.
Precision & Fit Standards
- Marginal gap ≤50μm for fixed dentures; stable fit without movement or gaps.
- Exact retention and stability
- Certificate Number:3015454817
- Issue Date:2025-05-06
- Expiry Date:2035-03-03
- Certificate Number:46774
- Issue Date:2025-08-07
- Expiry Date:2028-08-07
- Scope:Production and sales of customized fixed restorations, customizedremovable dentures and customized orthodontic appliances(export only)
- Issue Date:2025-01-02
- Scope:Fixed restorations (Bridges&Crowns), Removable Partial Denture,Orthodontics
