Every case leaves the laboratory with a production record: the design file, the material lot, the technician, the QC check and, where relevant, the registration certificate that covers the device.
The company is registered with China's NMPA for Class I, Class II and Class III dental devices. Class I covers components such as analogs, scan bodies, screwdrivers, impression copings and implant carriers. Class II covers custom fixed and removable prostheses, hybrid dentures, orthodontic appliances, aligners, retainers, surgical guides, temporary crowns and TMJ appliances. Class III covers custom abutments and screws, composite abutments, healing abutments, machinable abutment blanks, custom implant bridge frameworks and individualised fibre post-and-core systems.
Certificates are issued per product family. Customers preparing their own regulatory submissions can request the certificate, the technical specification and the material declaration for the family they are importing.
Zirconia blanks, titanium, CoCr, ceramics and resins are received with the manufacturer's certificate and lot number. The lot is recorded against the case, so a remake or a complaint can be traced back to the exact batch.
We do not substitute materials without written approval. If a specified blank is unavailable we stop and ask, rather than shipping a different material.
Each unit is checked on the model for margin fit, proximal contact, occlusion and surface finish. Photographs are taken at the same magnification for every case, which makes a remake claim comparable rather than a matter of opinion.
Surgical guides additionally get a sleeve position check and a printed surgical report. Full-arch frameworks are verified on the master model with analogs before the veneering stage.
Yes. Registration certificates, material certificates and declarations of conformity can be issued for the product family you import. Tell us the destination country when you request them.
If a unit does not fit the approved design, we remake it at no charge. Claims are assessed against the design file and the QC photographs, which is why we keep both.
We do not claim a certification we cannot evidence. Our quality documentation is built around the Chinese NMPA registration system; certificates and process documents are provided on request so you can assess them against your own requirements.
STL, PLY or conventional impressions. Named technician per account, DHL and FedEx delivery worldwide.