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Quality

Quality & certificates

Novodent SA works under a certified quality management system. Both certificates are below, with the issuing body, the number, the validity dates and the scope as printed on each document.

Certificates

  • Regulation (EU) 2017/745, Annex IX

    EU MDR quality management system certificate

    Certificate holder
    Novodent SA — SRN CH-MF-000023309
    Issued by
    Kiwa Cermet Italia
    Certificate number
    MDR 00122-A Rev.0
    Issued
    23 January 2026
    Validity
    Valid until 22 January 2031
    Scope
    Dental implants and accessories; surgical dental devices.

    PDF · 705 KB · EN · 2 pages · MDR 00122-A Rev.0

    View certificate (PDF) →Download

  • EN ISO 13485:2016

    ISO 13485 certificate

    Certificate holder
    Novodent SA, Yverdon-les-Bains
    Issued by
    QS Zürich AG
    Certificate number
    15579
    Issued
    First certified 22 May 2019
    Validity
    Current certificate valid 22 May 2025 – 21 May 2028
    Scope
    Design, manufacture, packaging, distribution and sale of sterile and non-sterile dental implants and instruments.

    PDF · 322 KB · EN · No 15579

    View certificate (PDF) →Download

Each certificate applies to the scope printed on it, and to nothing beyond it.

CE marking and regulatory identifiers

The devices are CE marked. These are the identifiers a clinician, distributor or authority may ask for.

Manufacturer
Novodent SA, Y-Parc Technopole, Avenue des Sciences 11, CH-1400 Yverdon-les-Bains, Switzerland
Single Registration Number (SRN)
CH-MF-000023309
Authorised representative in the EU
Emergo Europe B.V., Westervoortsedijk 60, 6827 AT Arnhem, Netherlands
Conformity
CE marked medical devices

Materials and traceability

  • Titanium alloy and commercially pure titanium

    Implants and prosthetic components are machined from Ti-6Al-4V ELI (Grade 5 ELI) or commercially pure titanium, as stated per product in the catalogs.

  • Reference and lot on every package

    Each sterile package carries the reference code, the lot number, the diameter and length, the sterilisation symbol and the expiry date, so a placed implant can be traced back to its batch.

  • Colour-coded platforms

    Platform colour coding runs through the implant packaging and the matching prosthetic components, so the right platform is recognisable before the package is opened.

  • Instructions for use

    Instructions for use are supplied with each device and describe the intended purpose, indications, contraindications, warnings and handling.

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