Certifications
The standards we hold ourselves to
Every case is produced to internationally recognised quality and safety standards, using CE- and FDA-certified materials. Our certifications are your guarantee of consistency, traceability and patient safety.
ISO 13485:2016
Quality Management System
NQA
- Standard
- ISO 13485:2016 (Medical Device Quality Management System)
- Certified entity
- Shenzhen Times Dental Laboratory Co., Ltd
- Certificate number
- 47269
- Scope
- Production and sales of customized fixed restorations, customized removable dentures and customized orthodontic appliances (within the scope of license qualification)
- Issue date
- 23 December 2019
- Latest audit
- 18 December 2025
- Reissue date
- 30 December 2025
- Valid until
- 23 December 2028
- Accreditation
- UKAS Management Systems (0015) · IAF Multilateral Recognition member
FDA
FDA Establishment Registration
U.S. FDA
- Establishment
- Shenzhen Times Dental Lab (China)
- Registration number
- 3008727912
- Current registration year
- 2025
- Authority
- U.S. Food & Drug Administration (FDA)
- Listed device categories
- Dental alloys (base, noble and gold-based metals), artificial posterior teeth with metal inserts, and noble-metal restorations
- Role
- Manufacturer / Contract Manufacturer
EUDAMED
European Database on Medical Devices
European Commission
- Manufacturer
- Times Dental Lab
- Role
- Manufacturer
- Actor ID / SRN
- CN-MF-000055484
- Country
- China (Shenzhen)
- EORI
- 914403006837752187
- Database
- EUDAMED (European Commission)
EU AR
EU Authorized Representative
Kingsmead Service B.V.
- Manufacturer
- Times Dental Lab
- Address
- Zonnehof 36, 2632 BE, Nootdorp, Netherlands
- Representative SRN
- NL-AR-000002066
- Agreement reference
- ERU26437V0
- Regulation
- (EU) 2017/745 (MDR)
- Valid
- 22 May 2026 – 21 May 2031
- Devices covered
- Custom Fixed Restorations, Custom Removable Restorations, Custom Orthodontic Appliances (custom-made devices)
MDR I
Dutch Health Ministry Registration
CIBG / Farmatec
- Authority
- CIBG / Farmatec — Ministry of Health, Welfare and Sport (Netherlands)
- Notification reference
- CIBG-20262167
- Product registration number
- NL-CA002-2026-85664
- Date received
- 22 May 2026
- Confirmed
- 27 May 2026
- Classification
- Medical device, Class I — Regulation (EU) 2017/745 (MDR)
- Registered products
- Custom Fixed Restorations, Custom Removable Restorations, Custom Orthodontic Appliances
Copies of all certificates and registration documents are available on request.