ISO 13485:2016 Certificate of Khai Nguyen Dental Lab
The same quality system is what makes remakes traceable to a case, a technician and a material batch. See our dental lab remake policy for how a claim is handled, and is outsourcing dental lab work safe for what this certificate does and does not prove.
Khai Nguyen Dental Lab Company Limited holds a quality management system certificate for medical devices to ISO 13485:2016, covering the manufacturing and trading of veneer porcelain teeth, metal-free porcelain teeth, alloy porcelain teeth, implant restorations, removable dentures and dental appliances. The certificate is issued by ISOCERT, carries a public retrieval code and can be verified online. Everything below is transcribed from the certificate currently in force.
| Certificate number | 9199293420717-MED |
|---|---|
| Standard | ISO 13485:2016 – Medical devices, quality management systems |
| Certified organisation | Khai Nguyen Dental Lab Company Limited. Head office and production location: 10/40-42 Xuan Dieu, Tan Son Nhat Ward, Ho Chi Minh City, Vietnam |
| Scope certified | Manufacturing and trading: veneer porcelain teeth, metal-free porcelain teeth, alloy porcelain teeth, implant restorations, removable dentures, dental appliances |
| Certification body | ISOCERT International Certification and Inspection Joint Stock Company (Hanoi, Vietnam), accredited by the Bureau of Accreditation (BoA) Vietnam under VICAS 067-MDMS, an IAF MLA signatory |
| Certification date | 11 March 2025 |
| Current issue | 6 April 2026 (2nd issue), under decision No. 060426.03/QD-ISOCERT |
| Valid until | 10 March 2028, with annual surveillance audits |
| Verify | ISOCERT certificate lookup, retrieval code 9199293420717 (or scan the QR code on the certificate) |
Certification history
- 11 January 2024: ISOCERT first issued certificate No. 9199293420717-MED to Khai Nguyen Lab as a business household, covering all-ceramic restorations and surgical guides (decision 110124.11/QD-ISOCERT).
- 11 March 2025: recertified to Khai Nguyen Dental Lab Company Limited with the expanded six-product-group scope shown above (decision 110325.02/QD-ISOCERT).
- 6 April 2026: second issue (decision 060426.03/QD-ISOCERT) following the annual surveillance audit. ISOCERT reissues the certificate every year; valid until 10 March 2028.
What ISO 13485 means for a clinic sending cases
ISO 13485 is the international quality-management standard written specifically for medical-device manufacturers. A restoration made to a dentist’s prescription is a custom-made medical device, so the standard applies directly to a dental laboratory. For a clinic, certification shows up in four concrete ways in how the lab operates.
Material traceability by lot. Every zirconia disc, pressing ingot and layering porcelain received is logged with brand, lot number and date. If a restoration fails, the lab can identify which material lot was used and which other cases share it, rather than knowing only that it was “zirconia”. This is why Khai Nguyen delivery notes state the material brand.
Documented, controlled production. Each step, from receiving the scan through design, milling or pressing, sintering, staining, firing and final inspection, has a written work instruction and a responsible person. Equipment such as sintering and porcelain furnaces is calibrated on a schedule. A unit that fails final inspection is recorded and remade before shipping, instead of the risk being passed on to your appointment.
Complaints and warranty handled on record. Every report about fit, contacts, shade or fracture is logged per case, analysed for cause (scan, preparation, design or production) and closed with a corrective action. This data is what lets the lab review the remake rate with you after the first cases, as described under criterion 9 of our guide to choosing a dental lab.
Independent audits on a schedule. Certification is not granted once and forgotten. ISOCERT performs a surveillance audit every year and a recertification audit at the end of each three-year cycle. If a lab stops maintaining its system, the certificate is suspended and the status appears on the public lookup page.
Other regulatory documents
In addition to ISO 13485, Khai Nguyen’s restoration product groups hold Certificates of Free Sale issued by the Vietnam Ministry of Health on 25 June 2025 (Nos. 25001419, 25001420, 25001421 and 25001425 CFS/BYT-HTTB). Scans of these are shown in the “Licences and certifications” section of our home page. Copies and commercial invoices are provided with international shipments where import formalities require them.
The products are also covered by Class B medical-device standard declarations accepted by the Ho Chi Minh City Department of Health on 11 April 2025: No. 250000953/PCBB-HCM for porcelain veneers and No. 250000951/PCBB-HCM for all-ceramic restorations. Both numbers appear on our delivery notes and on the lab’s published case posts.
Further reading
- Outsourcing to Khai Nguyen: workflow, turnaround, warranty
- How to choose a dental lab: a 10-point checklist
- Zirconia vs lithium disilicate vs feldspathic ceramics
- Ordering process and shipping
Need a stamped copy or additional documentation for your practice records? Contact us on WhatsApp +84 902 945 585 or through the contact page.
