Acrylic Resin Teeth · GL / GN type
NMPA Class III Registration
NMPA 20193171654
Marketing authorisation for acrylic resin teeth as a Class III medical device in China. A valid copy accompanies every shipment.
Home/Quality & Certifications
Quality and certification: compliance you can actually submit
NMPA Class III medical device registration, Class I manufacturing filings, a medical device manufacturing licence, and ISO 13485, ISO 9001 and CE certification. Every document available as a stamped scan.
Certification Overview
Certification is only useful if the buyer can verify it
For a distributor, certification is what makes market registration possible. For a dental laboratory, it is what gets you through a downstream supplier audit. For an overseas importer, it is what clears customs and compliance review.
Class I Dental Materials
Class I Manufacturing Filing
Filing No. 20160002
Manufacturing filing covering dental casting wax and modelling wax. Filed with the Huaxian Administration for Market Regulation.
Class III Dental Prosthetic Materials
Medical Device Manufacturing Licence
Licence No. 20160097
Valid until 16 November 2026, covering manufacture of Class III dental prosthetic materials.
Casting Wax · Type I soft / Type II hard
Dental Casting Wax Filing
Filing No. 20160005
Covers wax nets, sheets, sticks, baseplate sheets, thin sheets, clasp wax and the full Type II hard wax range.
Modelling Wax · Category 17-09-10
Dental Modelling Wax Filing
Filing No. 20200078
Obtained 25 May 2021, covering modelling wax for models and boxing.
Medical Device Quality Management System
ISO 13485
Certified
Covers design, production, inspection, warehousing and after-sales. 46 employees, including 5 QC staff and 4 dedicated inspectors.
Quality Management System
ISO 9001
Certified
Company-wide QMS supporting international customer audits and supply quality agreements.
EU Market Access
CE Mark
Certified
Compliance basis for EU and CE-recognising international markets, used with export documentation.
Using Our Documents
How to use these documents — and where the limits are
Market registration and tenders
We can supply scanned copies of the business licence, Medical Device Registration Certificate, Class I manufacturing filing certificate, Medical Device Manufacturing Licence and ISO 13485 / ISO 9001 certificates, stamped with the company seal on request.
Laboratory supplier audits
For downstream supplier audits we can provide the Supply Quality Assurance Agreement, inspection reports, technical requirement files and batch inspection records. The factory employs 46 people including 5 QC staff and 4 dedicated inspectors.
International market access
For export we prepare commercial documents in-house and can support buyers with product information and compliance files. Our CE Mark and ISO 13485 certification provide the basis for entry to the EU and to markets that recognise the CE mark. Requirements differ significantly by market, so we recommend confirming target-market requirements with our sales team before scheduling production.
What we cannot do
We will not issue documents covering products we do not hold registration for, and we will not certify indications outside the registered scope. If your market needs a specific certificate we do not hold, we will tell you rather than work around it.
Quality system · on the floorQuality Commitment
Three things we do not do
We do not supply unregistered products
Anything that falls under medical device regulation is registered or filed before it is sold.
We do not stretch the indications
Intended use follows the registration certificate and technical requirements. We do not promise performance outside the registered scope.
We do not blur batch responsibility
When a quality issue arises we trace the batch and check the records before assigning cause. Non-conforming product is returned or replaced per the agreement.
Supply quality assurance: Dimei Dental signs a Supply Quality Assurance Agreement with customers under China medical device regulations, defining the acceptance criteria for purchased materials, the sampling inspection requirement and the responsibilities of each party. The agreement runs for 2 years.
Verification
Certification questions buyers ask
Request a Quote or Sample Kit
Tell us your product category, specification and quantity. Dimei Dental replies within one business day with factory pricing, technical datasheets and a sample shipping plan. Thirty years of capacity behind every order.
- Global Sales
- +86 139 3722 7988
- sales@dimeick.com
- +86 139 3722 7988