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Why Can We Always Ensure Excellent Quality

Quality Control

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



Certification

Exceldent Dental Technology Development Co., Ltd. Certifications
Standard: FAD
Number: 3015454817
Issue Date: 2025-05-06
Expiry Date: 2035-03-03
Exceldent Dental Technology Development Co., Ltd. Certifications
Standard: IOS13485
Number: 46774
Issue Date: 2025-08-07
Expiry Date: 2028-08-07
Scope/Range: Production and sales of customized fixed restorations, customizedremovable dentures and customized orthodontic appliances(export
Exceldent Dental Technology Development Co., Ltd. Certifications
Standard: CE
Issue Date: 2025-01-02
Scope/Range: Fixed restorations (Bridges&Crowns), Removable Partial Denture,Orthodontics
Exceldent Dental Technology Development Co., Ltd. Certifications
Standard: iovocal
Exceldent Dental Technology Development Co., Ltd. Certifications
Standard: lvoclar
Exceldent Dental Technology Development Co., Ltd. Certifications
Standard: custom-made medical devices notifications
Exceldent Dental Technology Development Co., Ltd. Certifications
Standard: ivoclar
Exceldent Dental Technology Development Co., Ltd. Certifications
Standard: ivoclar
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