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